Optimising Molecular Radionuclide Therapy
SELFIE
OPTIMISING MOLECULAR RADIONUCLIDE THERAPY: The Role of Quantitative SPECT/CT & PET/CT and Radiation Dosimetry (SELFIE)
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
December 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2022
CompletedMarch 8, 2023
March 1, 2023
11 months
May 17, 2021
March 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
20 patients with Lu-Dotatate MRT response to therapy outcome as Assessed by response evaluation criteria in solid tumours RECIST (version 1.1)
* Standardised uptake value (SUV) will be extracted from SPECT/CT image using HERMES software at cycle 1 and cycle 4 of Lu-Dotatate MRT. * SUV values will be extracted from PET/CT image Pre and post Lu-Dotatate MRT using HERMES software. * The descriptive( mean, max, min, SD) and inferential (Wilcoxon signed-rank test and Spearman correlation) analysis will be applied to calculate the changes in SUV values in SPECT and PET. SUV changes will be correlated between SPECT \& PET.
started from the day of MRT administration at cycle 1 and cycle 4. (Total 4 MRT cycles, each cycle length 8-12 weeks). each participant time frame 1 year.
Whole-body gamma image time activity curve (TAC) versus patient-led external dose rate (SELFIE) TAC.
The data from both sets will be synthesised from all defined groups in this study to establish if correlation points exist between whole-body imaging and the selfie TAC. Nonlinear biexponential curve fitting will be applied using GraphPad statistics software to generate SELFIE slow and fast halflives and TAC. Hermes software will be used to generate whole-body gamma image TAC. Spearman correlation will be applied to test correlation.
SELFIE: 28 days measurements post administration of MRT activity. and Whole-body image:24 hrs post administration of MRT activity.
Secondary Outcomes (2)
Patient-led external dose measurement (SELFIE) area under the curve (AUC) change between cycle 1 & 4 MRT
1 year for Neuroendocrine tumours participants and 1 month for thyroid cancer and hyperthyroidism participants.
MRT patients Acceptance of patient-led monitor (SELFIE)
28 days post MRT activity administration.
Study Arms (3)
Neuroendocrine Toumours
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.
Thyroid Cancer
Patients will undergo 131I-Thyroid cancer 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.
Hyperthyrodism
Patients will undergo 131I-Hyperthyroidism MRT in accordance with existing protocols at GSTTFT. Patients will have one whole-body scan at 24 hr post MRT which will not involve any additional radiation. 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.
Interventions
Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).
SPECT/CT scan at 24-48 hr post MRT
3-6 months Pre and post-therapy PET/CT imaging
Following MRT administration, a standard whole body dosimetry measurement will be taken by 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.
Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.
Eligibility Criteria
Female and male patients undergoing molecular radionuclide therapy at GSTTFT using Lutetium-177 peptides for neuroendocrine tumour and I-131 for benign and malignant thyroid disease therapy will be invited to participate. The total sample size is estimated as 60 patients divided as 20 for patients receiving 131I for hyperthyroidism, 20 patients for 131I for thyroid cancer and 20 patients for177Lu-DOTATATE for neuroendocrine tumours. This sample should allow sufficient quantitative and dosimetry data to explore the research questions. The range in the number of patients who will be studied is intended to mitigate uncertainty regarding continuing restrictions related to the COVID-19 Coronavirus pandemic.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Londonlead
- Guy's and St Thomas' NHS Foundation Trustcollaborator
Study Sites (1)
Guy's and St Thomas Hospitals Foundation Trust
London, SE1 9RT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Lewington, Professor
King's College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
June 11, 2021
Study Start
December 9, 2021
Primary Completion
October 20, 2022
Study Completion
November 5, 2022
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- From June 2023 till June 2028.
- Access Criteria
- IPD will be shared with the lead sponsor King's College London. Name of Sponsor representative: Professor Reza Razavi Address: King's College London Vice President \& Vice-Principal (Research) Room 5.31, James Clerk Maxwell Building 57 Waterloo Road London SE1 8WA Telephone: Tel: +44 (0)207 8483224 Email: reza.razavi@kcl.ac.uk • Once the project has ended, data that supports published research and/or has long term value will be deposited with the university's research data repository to ensure long term preservation and accessibility. King's is committed to preserving research data for a minimum of 10 years since the last use of the data. Patient's images will be stored at HERMES medical system located in Nuclear Medicine Department at GSTTFT.
all IPD that underlie results in a publication.