Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04922801
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2021-05-17
Brief Title:
Optimising Molecular Radionuclide Therapy
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
OPTIMISING MOLECULAR RADIONUCLIDE THERAPY The Role of Quantitative SPECTCT PETCT and Radiation Dosimetry SELFIE
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 andor 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
Current radiation protection advice for patients receiving radionuclide treatment is appropriate
Radiopharmaceutical retention andor 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 Guys and St Thomas NHS Foundation Trust GSTTFT among patients undergoing MRT Pre and post-therapy blood tests treatment administration whole body and SPECTPET 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 SPECTPET 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 MedicinePET staff
All acquired images will be reconstructed and analysed by investigators using HERMES software as described in section 133
2 Imaging response assessment Planar Whole body SPECTCT and PETCT images will be acquired to assess uptake patterns and in the case of sequential treatments uptakeretention changes SPECTCT PETCT and whole-body scans will be performed in accordance with existing protocols at Guys and St Thomas NHS Foundation Trust This will not result in additional radiation exposure Schedule illustrated in 161 Appendix
The SUV of target and non-target tissues will be calculated from quantitative pre and post-therapy PETCT and post-therapy SPECTCT 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
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 SPECTPET 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 MedicinePET staff
All acquired images will be reconstructed and analysed by investigators using HERMES software as described in section 133
2 Imaging response assessment Planar Whole body SPECTCT and PETCT images will be acquired to assess uptake patterns and in the case of sequential treatments uptakeretention changes SPECTCT PETCT and whole-body scans will be performed in accordance with existing protocols at Guys and St Thomas NHS Foundation Trust This will not result in additional radiation exposure Schedule illustrated in 161 Appendix
The SUV of target and non-target tissues will be calculated from quantitative pre and post-therapy PETCT and post-therapy SPECTCT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None