Optimising Molecular Radionuclide Therapy

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Brief Title

Optimising Molecular Radionuclide Therapy

Official Title

OPTIMISING MOLECULAR RADIONUCLIDE THERAPY: The Role of Quantitative SPECT/CT & PET/CT and Radiation Dosimetry (SELFIE)

Brief Summary

      This project will examine the role of the whole body, PET and SPECT imaging before, during
      and after radionuclide treatment for 177Lu-Dotatate therapy, whole body and SPECT imaging for
      131-I for thyroid cancer therapy, and whole-body imaging for 131I for hyperthyroidism
      therapy. Whole-body and SPECT images will be linked to personal dosimeter readings to
      determine whether

        -  Current radiation protection advice for patients receiving radionuclide treatment is
           appropriate.

        -  Radiopharmaceutical retention and/or SUV change in patients undergoing repeated
           radionuclide treatments.

        -  Data combined from early (quantitative imaging) and late (whole-body dose rate
           measurements) could support individual treatment planning for patients undergoing
           repeated cycles of molecular therapy.
    

Detailed Description

      This cohort (retro- & prospective) study will be conducted at Guy's and St Thomas' NHS
      Foundation Trust (GSTTFT) among patients undergoing MRT. Pre and post-therapy blood tests,
      treatment administration, whole body and SPECT/PET imaging will be undertaken in strict
      accordance with existing GSTTFT approved protocols for each type of treatment. With the
      exception of hyperthyroid patients receiving I-131 therapy, these procedures are all part of
      the standard of care at GSTT. Hyperthyroid patients will be required to have one whole-body
      scan at 24hrs post-therapy activity administration in addition to their standard care. This
      will not result in additional radiation exposure.

      The decision to proceed with MRT will have been agreed upon at the relevant multidisciplinary
      meeting in accordance with current practice guidelines. Pre and post-therapy blood tests,
      whole body and SPECT/PET imaging will be followed as per current GSTTFT protocols. Patients
      will be asked to undertake the following:

        1. Neuroendocrine tumour and thyroid cancer patients: 1-7 days treatment whole-body gamma
           camera and SPECT /CT scan. (Part of standard of care post-treatment monitoring at
           GSTTFT).

           *Hyperthyroid patients: 24-hour post-treatment whole-body gamma camera scan. (Part of
           this research protocol, will not involve any additional radiation).

        2. Record SELFIE reading for 28 days post-therapy using the sheet provided. (Part of this
           research protocol).

        3. Complete feedback questionnaire. (Part of this research protocol). *Benign thyroid
           disease patients only: Reasonable travel expenses for the cost of an additional hospital
           visit for post-treatment scans will be reimbursed from the nuclear medicine research
           fund SPF228. (Maximum reimbursement 50 £)

      For the purpose of this study, two dosimetry methods will be used and compared.

        1. Whole-body self-monitored retention measurements study (SELFIE study):

           A handheld radiation monitor (ATOMTEX model AT6130, Belarus) will be used to follow the
           time course of radioactivity clearance in each patient. The measurement device (SELFIE
           device) will be introduced to patients by a member of the medical physics team. Patients
           will be shown how to operate and record readings obtained and will also receive
           illustrated written instructions to build confidence. The devices are user friendly and
           patients will be asked to record the measurements twice daily using a diary sheet,
           typically taking about one minute to complete on each occasion. Measurement can begin
           immediately following administration and will continue for 28 days afterwards.

           Following MRT administration, a standard whole-body dosimetry measurement will be taken
           by a medical physicist at 1 and 2 meters distance. The patient will begin to take SELFIE
           readings at the same time under supervision so that their records can be compared with
           the physicists' results.

           After 28 days, patients will be asked to return the diary sheet and SELFIE monitor by
           post to GSTTFT in a pre-paid, pre-addressed envelope.

           On completion of the 28-day exercise, patients will be asked to complete and return a
           feedback questionnaire.

           The paper record of SELFIE readings will be reviewed by investigators from each patient
           for 28 days post-therapy. All imaging will be performed at GSTTFT by specialist Nuclear
           Medicine/PET staff.

           All acquired images will be reconstructed and analysed by investigators using HERMES
           software as described in section 13.3.

        2. Imaging response assessment Planar Whole body, SPECT/CT and PET/CT images will be
           acquired to assess uptake patterns and, in the case of sequential treatments,
           uptake/retention changes. SPECT/CT, PET/CT and whole-body scans will be performed in
           accordance with existing protocols at Guy's and St. Thomas' NHS Foundation Trust. This
           will not result in additional radiation exposure. (Schedule illustrated in 16.1
           Appendix).

      The SUV of target and non-target tissues will be calculated from quantitative pre and
      post-therapy PET/CT and post-therapy SPECT/CT images. As a result, early tumour response and
      toxicity in patients undergoing molecular targeted radionuclide therapy can be studied.

      Patient-led dose rate (SELFIE) data and imaging data will be integrated to compare whole-body
      retention and evaluate sequential dose rate changes after repeated treatments.

      The quality of SELFIE data will be assessed against pre-specified standards (completeness of
      data collection, data deviation). Patient satisfaction will be evaluated from the feedback
      questionnaire.
    


Study Type

Observational [Patient Registry]


Primary Outcome

20 patients with Lu-Dotatate MRT response to therapy outcome as Assessed by response evaluation criteria in solid tumours RECIST (version 1.1)

Secondary Outcome

 Patient-led external dose measurement (SELFIE) area under the curve (AUC) change between cycle 1 & 4 MRT

Condition

Neuroendocrine Tumors

Intervention

Nuclear Medicine whole-body

Study Arms / Comparison Groups

 Neuroendocrine Toumours
Description:  Patients will undergo 177LU-Dotatate Neoruendocrine Tumours MRT in accordance with existing protocols at GSTTFT. In addition, all MRT patients will be asked to undertake the following non-invasive procedures.
Post-treatment gamma camera (Planar Whole Body & SPECT/CT) imaging to estimate disease/ target tissue and whole-body dose for Neuroendocrine and thyroid cancer MRT.
Post-treatment gamma camera planar Whole Body imaging for hyperthyroidism MRT.
Post-treatment patient-led self-monitoring.
Complete a feedback questionnaire relating to the use of self radiation monitoring.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

60

Start Date

June 2021

Completion Date

June 2022

Primary Completion Date

March 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients receiving MRT (177Lu-Peptide for Neuroendocrine Tumours and 131I for Thyroid
             Cancer and Benign Hyperthyroidism).

          -  Women of childbearing potential must use a reliable method of contraception and have a
             documented negative pregnancy test immediately prior to MRT administration in
             accordance with routine clinical practice.

          -  Able to comply with treatment plans, scheduled visits, all study whole body, SPECT/CT
             & PET/CT imaging and follow-up.

          -  Able to use a personalised dosimetry handheld device and record daily readings for 28
             days post MRT.

          -  Willing and able to give informed consent.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Any other considerations that may make the patient unable to tolerate whole body, PET
             or SPECT scans.

          -  Inability to use a personalised dosimetry handheld device and record the daily reading
             for 28 days post MRT.

          -  Participants who are involved in current research or have recently been involved in
             any research prior to recruitment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Valerie Lewington, Professor, 07900648803, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT04922801

Organization ID

IRAS288352


Responsible Party

Sponsor

Study Sponsor

King's College London

Collaborators

 Guy's and St Thomas' NHS Foundation Trust

Study Sponsor

Valerie Lewington, Professor, Principal Investigator, King's College London


Verification Date

May 2021