Neuroendocrine TumorsSELFIENCT04922801
Optimising Molecular Radionuclide Therapy
An observational study of Neuroendocrine Tumors and Hyperthyroidism, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Hyperthyroidism, Thyroid Cancer
- What is being tested?
- Nuclear Medicine whole-body, SPECT/CT imaging. and PET/CT imaging.
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Dec 2021to 5 Nov 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas Hospitals Foundation Trust
London, SE1 9RT
About this study
Official title: OPTIMISING MOLECULAR RADIONUCLIDE THERAPY: The Role of Quantitative SPECT/CT & PET/CT and Radiation Dosimetry (SELFIE)
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.
Read the 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:
- 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).
- Record SELFIE reading for 28 days post-therapy using the sheet provided. (Part of this research protocol).
- 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.
- 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.
- 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.
- Being tested
- Nuclear Medicine whole-body, SPECT/CT imaging., PET/CT imaging., Patient-led radiation monitor (SELFIE), LAB TEST
- Keywords
- MRT, Neuroendocrine tumours (NET), 177Lu-DOTATATE, SUV, Quantitative SPECT/CT, Thyroid cancer, I-131, Hyperthyrodism
- Medical subject headings
- Neuroendocrine Tumors, Hyperthyroidism, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuclear Medicine whole-bodyDiagnostic test
Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).
SPECT/CT imaging.Diagnostic test
SPECT/CT scan at 24-48 hr post MRT
PET/CT imaging.Diagnostic test
3-6 months Pre and post-therapy PET/CT imaging
Patient-led radiation monitor (SELFIE)Device
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.
LAB TESTDiagnostic test
Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Nuclear Medicine whole-body; Diagnostic Test: SPECT/CT imaging.; Diagnostic Test: PET/CT imaging.; Device: Patient-led radiation monitor (SELFIE); Diagnostic Test: LAB TEST | |
| 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. Receives: Diagnostic Test: Nuclear Medicine whole-body; Diagnostic Test: SPECT/CT imaging.; Diagnostic Test: PET/CT imaging.; Device: Patient-led radiation monitor (SELFIE); Diagnostic Test: LAB TEST | |
| 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. Receives: Diagnostic Test: Nuclear Medicine whole-body; Diagnostic Test: PET/CT imaging.; Device: Patient-led radiation monitor (SELFIE); Diagnostic Test: LAB TEST |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Data will be extracted from SELFIE for 28 days post MRT to generate AUC using biexponential nonlinear curve fitting to evaluate sequential dose rate change after repeated treatment.
Measured: 1 year for Neuroendocrine tumours participants and 1 month for thyroid cancer and hyperthyroidism participants.
MRT patients Acceptance of patient-led monitor (SELFIE)
All MRT groups identified in this study will complete the 5 Likert scale SELFIE Questionnaire (Agreement: Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree).
Descriptive analysis and non-parametric tests such as Spearman's correlation or chi-square test for independence for individual Likert-scale questions.
Questionnaire to be submitted to the research team after 28 days of using SELFIE
Measured: 28 days post MRT activity administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start9 Dec 2021
- Primary completion20 Oct 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Valerie Lewington, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922801
- Sponsor's protocol ID
- IRAS288352
- Acronym
- SELFIE
- Status last verified
- Mar 2023
- First submitted
- 17 May 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMISING MOLECULAR RADIONUCLIDE THERAPY: The Role of Quantitative SPECT/CT & PET/CT and Radiation Dosimetry (SELFIE)
- ClinicalTrials.gov ID
- NCT04922801
- Acronym / sponsor ID
- SELFIE / IRAS288352
- Keywords
- MRT, Neuroendocrine tumours (NET), 177Lu-DOTATATE, SUV, Quantitative SPECT/CT, Thyroid cancer, I-131, Hyperthyrodism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Record SELFIE reading for 28 days post-therapy using the sheet provided. (Part of this research protocol).
- 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.
- 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.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuroendocrine Toumours | – | Diagnostic Test: Nuclear Medicine whole-body, Diagnostic Test: SPECT/CT imaging., Diagnostic Test: PET/CT imaging., Device: Patient-led radiation monitor (SELFIE), Diagnostic Test: LAB TESTPatients 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 | – | Diagnostic Test: Nuclear Medicine whole-body, Diagnostic Test: SPECT/CT imaging., Diagnostic Test: PET/CT imaging., Device: Patient-led radiation monitor (SELFIE), Diagnostic Test: LAB TESTPatients 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 | – | Diagnostic Test: Nuclear Medicine whole-body, Diagnostic Test: PET/CT imaging., Device: Patient-led radiation monitor (SELFIE), Diagnostic Test: LAB TESTPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuclear Medicine whole-bodyGamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT). | Diagnostic test | Hyperthyrodism, Neuroendocrine Toumours, Thyroid Cancer |
| SPECT/CT imaging.SPECT/CT scan at 24-48 hr post MRT | Diagnostic test | Neuroendocrine Toumours, Thyroid Cancer |
| PET/CT imaging.3-6 months Pre and post-therapy PET/CT imaging | Diagnostic test | Hyperthyrodism, Neuroendocrine Toumours, Thyroid Cancer |
| Patient-led radiation monitor (SELFIE)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. | Device | Hyperthyrodism, Neuroendocrine Toumours, Thyroid Cancer |
| LAB TESTBiochemistry, haematology and tumour markers blood tests pre, post and during MRT. | Diagnostic test | Hyperthyrodism, Neuroendocrine Toumours, Thyroid Cancer |
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)
Time frame: 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.
* 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.
Whole-body gamma image time activity curve (TAC) versus patient-led external dose rate (SELFIE) TAC.
Time frame: SELFIE: 28 days measurements post administration of MRT activity. and Whole-body image:24 hrs post administration of MRT activity.
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.
2 secondary outcomes
Patient-led external dose measurement (SELFIE) area under the curve (AUC) change between cycle 1 & 4 MRT
Time frame: 1 year for Neuroendocrine tumours participants and 1 month for thyroid cancer and hyperthyroidism participants.
MRT patients Acceptance of patient-led monitor (SELFIE)
Time frame: 28 days post MRT activity administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Lewington, Professor principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Hyperthyroidism, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
20 patients with Lu-Dotatate MRT response to therapy outcome as Assessed by response evaluation criteria in solid tumours RECIST (version 1.1) (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.