Image, BodyNCT05355558
A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer
A study testing [18F]FLT-PET/MRI body scan in people with Image, Body and Cervix Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
This pilot study aims to monitor early tumour response based on [18F]FLT-PET/MRI scans and to determine the feasibility of personalised radiotherapy to spare active bone marrow areas identified by [18F]FLT-PET/MRI. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Image, Body, Cervix Cancer
- What is being tested?
- [18F]FLT-PET/MRI body scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSingapore
- Study dates
- 14 May 2019to 31 Dec 2022
- Phase
- Interventional
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice
- Histologically or cytologically confirmed cervical carcinoma
- FIGO staged IB to IVA
- Underwent MRI pelvis
- Underwent FDG-PET/CT or MRI abdomen or CT thorax and abdomen or Chest X ray for routine staging
- Planned for radical radiotherapy with or without chemotherapy
Show all 9Show fewer
- No distant metastasis in staging work up
- ECOG 0-2
- Age 21 or over (no upper age limit)
Who cannot join
- Patients scheduled for neoadjuvant chemotherapy
- Patients with previous hysterectomy or radiotherapy to the pelvis
- Patients who are pregnant or lactating
- Patients who do not meet the above mentioned inclusion criteria
- Patients who refuse to give and/or sign the informed consent
- Patients who currently have a pacemaker
Show all 10Show fewer
- Patients who have a history of serious adverse events related to a previous MRI or PET/CT
- Patients who are unable to undergo MRI scanning
- Patients with a known allergy against any component of the contrast enhancing agent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 169610
Kiattisa S Sommat, 64368000, kiattisa.sommat@singhealth.com.sg
About this study
This pilot study aims to monitor early tumour response based on [18F]FLT-PET/MRI scans and to determine the feasibility of personalised radiotherapy to spare active bone marrow areas identified by [18F]FLT-PET/MRI. Bone marrow within the pelvis will be outlined by employing 18FLT PET to identify active BM within bony structures. Subsequently, treatment plans with various conformal radiotherapy techniques will be generated with different optimization approaches toward bone marrow while ensuring adequate tumor coverage.
Dosimetric comparison amongst plans will be carried out.
- Conditions
- Image, Body, Cervix Cancer
- Being tested
- [18F]FLT-PET/MRI body scan
- Keywords
- PET/MRI, Imaging technique, Cervix Cancer, FLT PET radiotracer, Response assessment, Radiation treatment
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FLT-PET/MRI body scanDiagnostic test
[18F]FLT-PET/MRI body scan will be done at
- Visit 2 (Baseline-Pre-Treatment FLT-PET/MRI) which will occur between 1 to 28 days prior to initiation of radiotherapy.
- Visit 3 (During Treatment FLT-PET/MRI) which will occur between week 4 to week 5 of External Beam Radiotherapy (before brachytherapy).
At these visits:
- Obtain vital signs and weight in kg before FLT administration.
- Record the dose of FLT received and injected. (**specify dose: 1mCi per 10kg. Maximum injected dose: < 10mCi per patient.)
- Place one (1) IV catheters into the participant's arm vein to inject the bolus of FLT.
- Perform a saline flush following the FLT injection.
- Body PET/MRI will be performed after FLT injection.
- Time of injection of FLT and time of scan will need to be recorded.
| Study group | Role | What they receive |
|---|---|---|
| [18F]FLT-PET/MRI body scan | Experimental | Not described Receives: Diagnostic Test: [18F]FLT-PET/MRI body scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the feasibility of [18F]FLT-PET/MRI imaging for early prediction of treatment by comparison of changes in baseline SUV uptake at Week 4-5 of External Beam Radiotherapy
Measured: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Secondary outcomes (7)
Compare SUV uptake of FLT with FDG PET at diagnosis
Measured: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Compare SUV uptake of FLT before and after chemoRT
Measured: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
To compare differences in tumor and regional staging between PET/MRI, PET/CT and MRI scans, determined from the tumor size and extent of local involvement
Measured: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of image quality and image fusion of PET/MRI data with the treatment planning CT for marrow sparing RT plan
Measured: Through patient treatment completion, an average of 3 months
Compare changes in stimulated radiation treatment volume when derived from PET/MRI vs PET/CT vs MRI
Measured: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Compare VMAT versus IMRT versus proton versus tomotherapy for best marrow sparing plan
Measured: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
To determine the correlation of [18F]FLT parameters as baseline, during treatment and change in [18F] FLT parameters with clinical outcome and response
Measured: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start14 May 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image, BodyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355558
- Sponsor's protocol ID
- LEGEND19
- Status last verified
- Sep 2021
- First submitted
- 12 Jan 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer
- ClinicalTrials.gov ID
- NCT05355558
- Acronym / sponsor ID
- LEGEND19
- Conditions
- Image, Body, Cervix Cancer
- Keywords
- PET/MRI, Imaging technique, Cervix Cancer, FLT PET radiotracer, Response assessment, Radiation treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 May 2022 (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 pilot study aims to monitor early tumour response based on [18F]FLT-PET/MRI scans and to determine the feasibility of personalised radiotherapy to spare active bone marrow areas identified by [18F]FLT-PET/MRI. Bone marrow within the pelvis will be outlined by employing 18FLT PET to identify active BM within bony structures. Subsequently, treatment plans with various conformal radiotherapy techniques will be generated with different optimization approaches toward bone marrow while ensuring adequate tumor coverage.
Dosimetric comparison amongst plans will be carried out.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FLT-PET/MRI body scan | Experimental | Diagnostic Test: [18F]FLT-PET/MRI body scan |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice
- Histologically or cytologically confirmed cervical carcinoma
- FIGO staged IB to IVA
- Underwent MRI pelvis
- Underwent FDG-PET/CT or MRI abdomen or CT thorax and abdomen or Chest X ray for routine staging
Key exclusion criteria (10 listed)
- Patients scheduled for neoadjuvant chemotherapy
- Patients with previous hysterectomy or radiotherapy to the pelvis
- Patients who are pregnant or lactating
- Patients who do not meet the above mentioned inclusion criteria
- Patients who refuse to give and/or sign the informed consent
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 |
|---|---|---|
| [18F]FLT-PET/MRI body scan[18F]FLT-PET/MRI body scan will be done at * Visit 2 (Baseline-Pre-Treatment FLT-PET/MRI) which will occur between 1 to 28 days prior to initiation of radiotherapy. * Visit 3 (During Treatment FLT-PET/MRI) which will occur between week 4 to week 5 of External Beam Radiotherapy (before brachytherapy). At these visits: * Obtain vital signs and weight in kg before FLT administration. * Record the dose of FLT received and injected. (**specify dose: 1mCi per 10kg. Maximum injected dose: < 10mCi per patient.) * Place one (1) IV catheters into the participant's arm vein to inject the bolus of FLT. * Perform a saline flush following the FLT injection. * Body PET/MRI will be performed after FLT injection. * Time of injection of FLT and time of scan will need to be recorded. | Diagnostic test | [18F]FLT-PET/MRI body scan |
Primary outcome
To determine the feasibility of [18F]FLT-PET/MRI imaging for early prediction of treatment by comparison of changes in baseline SUV uptake at Week 4-5 of External Beam Radiotherapy
Time frame: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
7 secondary outcomes
Compare SUV uptake of FLT with FDG PET at diagnosis
Time frame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Compare SUV uptake of FLT before and after chemoRT
Time frame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
To compare differences in tumor and regional staging between PET/MRI, PET/CT and MRI scans, determined from the tumor size and extent of local involvement
Time frame: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Assess the feasibility of PET/MRI in the radiation treatment planning workflow with respect to the adequacy of image quality and image fusion of PET/MRI data with the treatment planning CT for marrow sparing RT plan
Time frame: Through patient treatment completion, an average of 3 months
Compare changes in stimulated radiation treatment volume when derived from PET/MRI vs PET/CT vs MRI
Time frame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Compare VMAT versus IMRT versus proton versus tomotherapy for best marrow sparing plan
Time frame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
To determine the correlation of [18F]FLT parameters as baseline, during treatment and change in [18F] FLT parameters with clinical outcome and response
Time frame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
Related trials for Image, Body
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]FLT-PET/MRI body scan in people with Image, Body and Cervix Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 9 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 May 2022. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiattisa Sommat (64368000, kiattisa.sommat@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the feasibility of [18F]FLT-PET/MRI imaging for early prediction of treatment by comparison of changes in baseline SUV uptake at Week 4-5 of External Beam Radiotherapy (time frame: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)). 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 2 May 2022.