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Optimising Molecular Radionuclide Therapy (SELFIE)

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ClinicalTrials.gov Identifier: NCT04922801
Recruitment Status : Not yet recruiting
First Posted : June 11, 2021
Last Update Posted : September 1, 2021
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Hyperthyroidism Thyroid Cancer Thyroid Carcinoma 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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: OPTIMISING MOLECULAR RADIONUCLIDE THERAPY: The Role of Quantitative SPECT/CT & PET/CT and Radiation Dosimetry (SELFIE)
Estimated Study Start Date : September 30, 2021
Estimated Primary Completion Date : April 20, 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Cancer

Group/Cohort Intervention/treatment
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.
Diagnostic Test: Nuclear Medicine whole-body
Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).

Diagnostic Test: SPECT/CT imaging.
SPECT/CT scan at 24-48 hr post MRT

Diagnostic Test: PET/CT imaging.
3-6 months Pre and post-therapy PET/CT imaging

Device: 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.


Diagnostic Test: LAB TEST
Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.

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.
Diagnostic Test: Nuclear Medicine whole-body
Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).

Diagnostic Test: SPECT/CT imaging.
SPECT/CT scan at 24-48 hr post MRT

Diagnostic Test: PET/CT imaging.
3-6 months Pre and post-therapy PET/CT imaging

Device: 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.


Diagnostic Test: LAB TEST
Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.

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.
Diagnostic Test: Nuclear Medicine whole-body
Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).

Diagnostic Test: PET/CT imaging.
3-6 months Pre and post-therapy PET/CT imaging

Device: 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.


Diagnostic Test: LAB TEST
Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.




Primary Outcome Measures :
  1. 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.


  2. 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.



Secondary Outcome Measures :
  1. 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. ]
    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.

  2. MRT patients Acceptance of patient-led monitor (SELFIE) [ Time Frame: 28 days post MRT activity administration. ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04922801


Contacts
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Contact: Tahani O Alkahtani, MSC 07900648803 tahani.alkahtani@kcl.ac.uk
Contact: Lefteris Livieratos, PhD 07801802148 lefteris.livieratos@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas Hospitals Foundation Trust
London, United Kingdom, SE1 9RT
Contact: Rachel Fay    2071887188    R&D@gstt.nhs.uk   
Principal Investigator: Valerie Lewington, Professor         
Sub-Investigator: Lefteris Livieratos, PhD         
Sub-Investigator: Tahani O Alkahtani, MSc         
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Valerie Lewington, Professor King's College London
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT04922801    
Other Study ID Numbers: IRAS288352
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication.
Supporting Materials: Study Protocol
Informed Consent Form (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
MRT
Neuroendocrine tumours (NET)
177Lu-DOTATATE
SUV
Quantitative SPECT/CT
Thyroid cancer
I-131
Hyperthyrodism
Additional relevant MeSH terms:
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Thyroid Neoplasms
Neuroendocrine Tumors
Thyroid Diseases
Hyperthyroidism
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue