SOUTH AFRICAN PET USERS ASSOCIATION (SAPUA)

REPORT ON THE MEETING HELD ON THE TYGERBERG HOSPITAL PREMISES ON THE 4TH OF DECEMBER 2004.

  1. INTRODUCTION

The South African Society of Nuclear Medicine (SASNM) arranged a meeting to discuss setting up, under their auspices, a formal platform that could serve the interests of role players in the field of Positron Emission Tomography (PET). The above meeting was convened with the following purposes in mind:

·                Defining a mandate for the SAPUA.

·                Formulating goals for the SAPUA for 2005.

·                Developing strategies and implementation guidelines for 2005.

·                Putting a management structure with appropriate office bearers in place to deal with the PET agenda in the following two years [2005 -2006].

2. REGISTER

The meeting was attended by:

 

	Capacity
Prof M Sathekge	President, SASNM / Medunsa
Prof Mario Iturralde	Private Practice (retired)
Dr Katienka Venter	Pretoria Academic Hospital
Prof Jan Esser	Wits Donald Gordon Medical Centre
Prof Annare Ellmann	Stellenbosch University / Tygerberg Hospital
Prof Ben van Heerden	Stellenbosch University
Dr James Warwick	Stellenbosch University / Tygerberg Hospital
Mrs Geraldine Philotheou	Pentech Groote Schuur
Mr John Boniaszczuk	Groote Schuur Hospital
Ms Gaseeda Boltmann	Groote Schuur Hospital
Dr R Jackpersad	Private Practice, Durban
Dr MN Naidoo	Private Practice, Durban
Dr Heinz Morkel	Private Practice, Panorama
Dr Ria Bester	Private Practice, Bellville
Mr Neil LLoyd	Private Practice, Bellville
Dr Pieter Botha	Private Practice, Cape Town
Mrs Colleen Tully	AEC-Amersham
Mr Koos Franken	Philips
Mr Yunus Munga	Siemens
Mrs Joani Landman	GE
Mr Roland van Gogh	NTP Radioisotopes (Pelindaba)
Dr Hymne Bouma	Private
Prof John Sharpey-Schafer	iThemba LABS, Faure
Dr Dan Jones	iThemba LABS, Faure
Dr Clive Naidoo	iThemba LABS, Faure
Dr Nico van der Walt	iThemba LABS, Faure
Dr Deon Steyn	iThemba LABS, Faure
Dr Zinhle Buthelezi	iThemba LABS, Faure
Dr K Aardaneh	iThemba LABS, Faure
Miss Claudia Davids	iThemba LABS, Faure
Miss Rayana Anthony	iThemba LABS, Faure
Ms Deidré Prince	iThemba LABS, Faure
Ms Aurelia Pakati	iThemba LABS, Faure
Mr Etienne Vermeulen	iThemba LABS, Faure
Mr Hilton Thomas	Tygerberg Hospital
Mrs Brenda Fikani	iThemba LABS, Faure
Mr Frans de Graaff	MCMS cc
Mrs Thea Eiselen	SASNM Council / Peninsula Technikon Tygerberg
Dr Sietske Rubow	SASNM Council: Organiser
Dr Bernard Slabbert	Facilitator

 

Apologies

S Wynchank, M Mann, B Meyer, A Otto, F Peer, L Chipeya, P du Toit, J le Roux, M van der Walt, G Kemp, G Lange, D Rubin, G Engelbrecht, A Forman, Dr J Basson, V Kritzinger, P Freedman, A Fataar

 

3.   INTRODUCTION AND ORIENTATION

  As an introduction and orientation to the discussions short information sessions were conducted by delegates representing a variety of stakeholders. They were:

Dr N van der Walt  Other PET radionuclides

Mr R van Gogh Plans at NTP

Prof J Sharpey-Schafer Possible location of a small cyclotron and FDG producing facilities at Wits Campus

Prof J Esser  PET service and development at Wits DGMC

Dr D Jones PET at iThemba LABS MRMC

Prof M Sathekge PET in Gauteng Academic Hospitals

Dr H Morkel PET in the Western Cape

Mr G Kemp Plans for PET [Not presented] 

Prof J Esser PET imaging - Practical considerations.

  Copies of the above talks that were available are attached as annexure to this report.

   

4.   APPROPRIATENESS OF "PET FORUM" AS A NAME

From the onset of discussions the working name for the new organization was the “PET FORUM”. The meeting expressed some concern that the group would be known as the "PET FORUM". It was suggested that the management group to be elected should consider changing the name. The opinion was expressed that the name "PET FORUM" implied that the group is merely a talk shop and that it would not add real value to the deployment and future sustainability of PET in the RSA. If the organisation were to serve the purpose of identifying, developing and sustaining synergies amongst the various role players, thus ensuring greater coherence and focus amongst themselves it had to be more than a talk shop. Possible alternatives to be considered could be "THE PET ASSOCIATION OF THE RSA" or "THE ASSOCIATION OF PET USERS IN THE RSA."

After consideration by the initial members of the management committee, the name “South African PET Users Association” (SAPUA) was arrived at.

 

5.    MANDATE AND ROLE OF SAPUA

There was general agreement that the establishment of a body such as the SAPUA was indeed necessary at this point in time. Furthermore it should function under the ambit and authority of the SASNM. (One group suggested that the possibility of the “FORUM” becoming a “formal” organization with its own constitution, Board and supporting infrastructure should be investigated.)

  Some of the reasons cited included:

·                It would serve the purpose of enhancing effective communication amongst all role players. As part of this it could be a legitimate bridge builder between the private and public sectors, and amongst specialities involved with PET, ensuring productive collaboration in serving the needs of the patient.

·                It could contribute to greater coherence and focus amongst role players in the field of PET in serving the needs of patients.

·                It could be a major role-player in developing, establishing and sustaining an effective regulatory and policy framework environment for the deployment and on-going utilization of PET technology in the RSA.

 

The SAPUA is mandated as the co-ordinating [all the role players], advisory [regarding licensing, regulations, and trends in the field], and regulatory [sole or in partnership] body for all PET related issues in the RSA. Furthermore it is mandated to play a role in the promotion of PET in the RSA, and to establish a national policy for the development of PET facilities in SA. As such it should actively pursue the functions set out above. It should serve as and be recognized by the appropriate authorities as the legitimate national lobbying/communication/advisory/regulatory platform for PET related issues in the RSA.

The meeting felt that membership should be inclusive of ALL the relevant role players and should reflect the diverse spectrum of governmental agencies, providers of PET services, manufacturers of PET equipment and materials, academia, health professionals (Nuclear Medicine and other specialities), scientists, training institutions, related professional bodies, health insurers etc. Membership of the SAPUA is therefore open to all individuals or organizations with an interest in PET in South Africa.

Vision Statement:      The South African PET Users Association strives to actively increase the quality of health of all the peoples of the RSA through implementation of PET technologies that are appropriate to the Health Care needs of the RSA, conforming to international standards and being responsible and accountable to the needs of the people of the RSA.

 

It is recommended that the SAPUA initially primarily focus on the following issues:

·                Ensuring a coherent, well structured Human Capital development strategy for the RSA. [Clarification on possible co-coordinating and accrediting roles; role in the provision of clinical platforms for training and developing appropriate curricula content].

·                Building and sustaining national and international communication networks.

·                PET Radiopharmacy.

·                Gamma-camera based PET vs. dedicated PET vs. PET-CT

·                The implementation of PET in the RSA. Important issues in implementation are a marketing/educational drive focusing in particular on other Healthcare professional groups [Co-optition] and the evaluation, and negotiation of future tariff/fee structures.

·                Co-ordination of sponsorships for training and research

   

6.       GOALS FOR 2005

  It was suggested that the meeting should identify and then focus on the most important goals to be pursued in the immediate future [2005]. The following goals were drafted for consideration by the management group:

6.2          Propose initial PET needs for the country as a whole and use and share this for the purposes of strategic planning and advocacy. 

6.3          Develop and execute a comprehensive communication strategy for the SAPUA.

6.4          Assess the requirements and availability of adequately and appropriately trained personnel nationally and based on this

·       recommend minimum requirements for training and accreditation until training in the RSA is feasible

·       Recommend an accreditation system to the relevant authorities in SA

·       in the long term, develop a comprehensive training and development strategy for all related categories of staff in the health- and other related sciences

6.5          Establish, through consultation, a set of commonly approved national protocols and accompanying standards to be followed by all operating in a PET or PET related environment.

6.6          Develop, through consultation and negotiation with critical role players, acceptable unified tariff codes.

6.7          Develop a comprehensive financial strategy for the SAPUA.

   

7.          IMPLEMENTATION FRAMEWORK FOR GOALS.  

GOAL	MEASURABLE OUTCOME	STRATEGY/ACTIONS	TIME FRAME	RESPONSIBILITY
Initial nature and mandate of SAPUA. Membership and Committee [Goal 6.1]	Document defining mandate, vision and core business activities. A membership profile that truly represents all the key stakeholders in the value chain [Med. Insurance companies, Academia, DOH, private sector (N Med/ Radiol/ Oncol), Isotope producers, ?MRC]  of  PET technology  in the RSA.   Complete Commitee	Finalizing and approving content of this report. Appoint Secretary Draw up a membership list         Contact RSSA and SASCRO for nominees to serve on the SAPUA Committee	January 2005   January 2005   February 2005	Management Committee   Management Committee Secretary   Management Committee
Propose initial PET needs for the country. [Goal 6.2]	Document suggesting initial PET needs	Members of PET SAPUA asked for proposals. Final recommendation then made.	June 2005	Management committee to appoint task group.
Comprehensive Communication Strategy. [Goal 6.3]		Develop a communication strategy to convey all the relevant information about the SAPUA. Inform all the key stakeholders. Consider editorial in SAMJ and other media. Establish contact with Minister of Health.	March 2005 Communication to start as soon as possible. (ongoing activity).	Management committee to appoint task group.   To be set out in communication strategy
Human Capital training/development. [Goal 6.4]	Knowledge/skills Register. National plan for training and development. Plan needs to reflect: - Conversion courses for present NM staff to become competent in PET technology. - IAEA Fellowships - Role of ICT national training facility at the University of Stell. - Training of referring physicians - Posts in Academic Hospitals - Sponsorships from industry for training.	Identify disciplines [physicians, med. physicists, technologists, radio-pharmacists, referral base etc.], training sites and institutions. Determine contents of courses and accreditation - both with prof. societies and governmental agencies. Clarify role of telemedicine and IT in training.	Report back at feedback meeting in March.   Proposals made by end 2005	Management committee to appoint task group(s).
National Protocols and accompanying standards [Goal 6.5]	- Protocols/ Standards for: - Radio-pharmaceutical production - Clinical indications - PET scanning and intepretation - Quality assurance of instrumentation	Modify existing protocols in use in Europe and US	end 2005	Management committee to appoint task group(s).
Tariffs [Goal 6.5]	Tariff code manual for PET and PET related activities	Determine acceptable tariff structures for: - single exit price FDG - Gamma-camera based PET - dedicated PET - PET/CT	June 2005 [Feedback meeting March]	Proposed task group: - Chair or nominee of SASNM. - Chair or nominee of ANP - Head of an Academic Department - President or nominee of Radiology Society - Representative from FDG production facilities.
Develop a financial strategy for the SAPUA. [Goal 6.6]	Two-year budget for SAPUA.	Appoint Treasurer Open a separate bank account in the name of the SAPUA. Secure financial resources for SAPUA to initiate and sustain mandate and realise goals. Draw up budget	February 2005 February 2005 Start as soon as possible. (ongoing activity). March 2005	Management committee Treasurer Management committee Treasurer

   

8.              Management Committee

After some deliberations the meeting to decided to elect a management committee with a two-year term of office. They were mandated to take responsibility for the implementation of the outcome of the meeting and to report back on progress in March 2005.  A committee comprising of a chairperson, one representative each from Academia, the Private Sector, the Industry, Radiology, Oncology and one additional member were proposed. The following members were then elected. 

 

Chairperson	Dr James Warwick	Tygerberg/Stellenbosch
Academia	Prof M Sathekge	Medunsa
Private Practice	Dr H Morkel	Private Practice
Industry	Dr C Naidoo	iThemba LABS, Faure
Additional member	Mrs Thea Eiselen	Cape Peninsula University of Technology
Radiology		Radiology Society of SA to nominate
Oncology		SA Society of Clinical and Radiation Oncology to nominate

 

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PRODUCTION OF ¹⁸F-FDG BY iTHEMBA LABS

  C Naidoo

iThemba LABS, P.O. Box 772, Somerset West, 7129, South Africa

 

Positron Emission Tomography (PET) has emerged as a powerful diagnostic tool for the evaluation of cancer patients.  Currently, most of these studies are performed with the glucose analog ¹⁸F-FDG.  iThemba LABS plans to make available ¹⁸F-FDG (t_1/2 = 110 minutes) by June/July 2005.  The proposed production schedule is presented here.  

 

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Other PET radionuclides

  N van der Walt

iThemba LABS, P.O. Box 772, Somerset West, 7129, South Africa

 

iThemba LABS is investigating the possibilities to produce a ⁶⁸Ge/⁶⁸Ga generator and also ⁶⁴Cu and ⁸⁶Ye.  ⁶⁴Cu and ⁸⁶Ye are PET radionuclides which are used for PET studies.  The half-lives of ⁶⁸Ga, ⁶⁴Cu and ⁸⁶Ye are respectively 68.3 minutes, 12.7 hours and 14.74 hours.    

_ _ _ _ _

   

Possible location of a small cyclotron and ¹⁸FDG producing facilities at the "New Schonland", Wits Campus, Gauteng

 

JF Sharpey-Schafer and the iThemba LABS Team

 

Abstract:  The DST and Wits have agreed to transfer the Schonland Laboratory to the NRF/iThemba LABS from 1st January 2005.  This opens the possibility of locating a small cyclotron and ¹⁸FDG producing facilities at a central Gauteng site which has the technology and institutional skills required to support reliable production.  The Wits site is within half-an-hour supply time for all major hospitals in Gauteng and for the International Airport.

   

PET AT THE iTHEMBA LABS MAJOR MEDICAL RADIATION CENTRE

D T L Jones

 

iThemba LABS is currently planning a new Major Radiation Medicine Centre (MRMC) which will include state-of-the-art radiation therapy and imaging equipment.  The main facilities will be a dedicated 230 MeV cyclotron for proton therapy with two gantries and two fixed beam arrangements; two linear accelerators for electron and x-ray therapy; CT, MRI and PET/CT scanners.  The current neutron therapy facility will continue to operate.  Although CT is the primary modality for image based treatment planning, the use of PET is playing an increasingly important role in delineating tumours, providing tumour stage and other physiological information, identifying radiation resistant tumours and predicting treatment response.  ¹⁸F-FDG is the main imaging agent;  but other agents are being used and new ones’ developed.  However, lack of anatomical definition makes registration with a CT image a necessity.  In addition the future use of short-lived positron emitters such as ¹¹C, ¹³N and ¹⁵O produced in a small on-site cyclotron will be possible at iThemba LABS.  The MRMC will provide unique advanced radiation medicine facilities for local disadvantaged patients as well as for better off local and international patients, there will be extensive opportunities for research and training and its implementation will further enhance the reputation of South African medical science.  

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NTP Radioisotopes (Pty) Ltd

Press Release – 2 December 2004  

Groundbreaking development for healthcare in South Africa - NTP Radioisotopes (Pty) Ltd and Community Investment Holdings (Pty) Ltd partner to establish a PET (positron emission tomography) isotopes production and distribution facility at Pelindaba, South Africa.

 

In a landmark development that will herald the introduction to South Africa of the world’s most sophisticated and effective medical diagnostic imaging modality, NTP Radioisotopes (Pty) Ltd, (a subsidiary of Necsa Ltd) and Community Investment Holdings (Pty) Ltd (a 100 % black owned, Tshwane-based, investment company) have signed an agreement to enter into a partnership that will provide the radioisotope necessary for the Positron Emission Tomography (PET) diagnostic imaging procedure to be performed by nuclear medicine physicians in association with radiologists.

 

NTP and CIH have committed to the establishment of a company that will produce the key PET isotope and its pharmaceutical derivative at the Pelindaba nuclear complex where other, reactor-produced isotopes and related products for healthcare applications have been made for many years. The product will be provided daily to nuclear medicine specialists and radiologists to allow them to obtain images of patients using sophisticated PET and PET-CT scanners (cameras) and from which accurate detection and diagnosis of disease can be made.

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  PET in Gauteng Academic Hospitals

Prof Mike Sathekge

Chief Specialist/Head of Nuclear Medicine Department: Medunsa/Dr George Mukhari Hospital

 

1. Background

Gauteng is the most populated province in South Africa and also has three tertiary centers (Medunsa, UP, Wits). As the three training tertiary centres, the accurate diagnosis, staging and individualised management of therapy depends on the accuracy of imaging used to define active disease. South Africa is the most established country in Africa with regards to health, welfare and economy, however we are lacking behind Egypt with regards to PET and only PET. The academics in Gauteng and some of the government official have no doubt that PET is an indispensable tool and thus a must to have in South Africa’s most populous province.

A PET Imaging Centre will further establish Gauteng as a centre of excellence for imaging, in particular cancer imaging. The centre will provide a distribution point for PET radiopharmaceuticals to support other centres in the Free State, Limpopo, Kwa-Zulu Natal and beyond.  

Currently all the academic hospitals are involved in lobbying the support of the Deans and CEO’s, based on the objectives below.

 2. The objectives of the need for PET/CT are:

 2.1. Patient Care

1. To improve the diagnosis, staging and outcome of patients with cancer
2. To reduce the morbidity of patients with cancer by the avoidance of surgery and appropriate monitoring of chemotherapy
3. To Improve the availability of imaging services to a wide population in the light of new and developing practice across Oncology, Coronary Heart Disease and Neurology
4. To ensure continuity of patient care within the care pathway

 2.2. Performance

1. To improve standards of care in line with International Cancer Accreditation Standards
2. To meet the targets of improved cancer management by Gauteng Health Department.
3. To meet the needs of the oncologists for the diagnosis, staging and monitoring of cancer in the light of new and developing practice

2.3. Professions

1. To improve the recruitment and retention of staff essential to maintaining a nuclear medicine service in Gauteng by providing a PET imaging facility
2. To ensure the continued professional development of staff working in the light of new and developing practice
3. To improve the recruitment to other consultant posts through the availability of leading edge technology

 2.4. Partnership

1.       To provide cancer imaging services for other healthcare organisations (private & public)  in Gauteng, Free State, Limpopo North West and beyond.

2.       To act as a central resource for service development, education and training for other healthcare organisations (private & public)  in Gauteng, Free State, Limpopo, North West  and beyond.

 2.5. Research and Development

1. To provide research facilities that support the Cancer Network and ensuring that patients are recruited to clinical trials
2. To undertake leading-edge drug development research in collaboration with the Medunsa, UP, Wits, Private sector and other industrial, charitable and research councils (MRC, NRF).

3. Conclusion

Finally and most important: A good PET Center is based on a good team. It is not a solopractice. From the start, we will involve many people in Gauteng and Nationally, to get their support (patient recruitment), their expertise (scientists, finance people), and their money (government officials, medical aids) and take the necessary time to build a group of people who share the same goals and morality. Therefore, as a compromise position to get the process going we should also consider the option of Mobile PET. More so that Gauteng is ± 1 hr away from one border to the other.