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A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer

Primary Purpose

Image, Body, Cervix Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
[18F]FLT-PET/MRI body scan
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Image, Body focused on measuring PET/MRI, Imaging technique, Cervix Cancer, FLT PET radiotracer, Response assessment, Radiation treatment

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice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
  • No distant metastasis in staging work up
  • ECOG 0-2
  • Age 21 or over (no upper age limit)

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • National Cancer Centre SingaporeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]FLT-PET/MRI body scan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Compare SUV uptake of FLT with FDG PET at diagnosis
Compare SUV uptake of FLT before and after chemoRT
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
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
Compare changes in stimulated radiation treatment volume when derived from PET/MRI vs PET/CT vs MRI
Compare VMAT versus IMRT versus proton versus tomotherapy for best marrow sparing plan
To determine the correlation of [18F]FLT parameters as baseline, during treatment and change in [18F] FLT parameters with clinical outcome and response

Full Information

First Posted
January 12, 2022
Last Updated
April 27, 2022
Sponsor
National Cancer Centre, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT05355558
Brief Title
A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer
Official Title
A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Image, Body, Cervix Cancer
Keywords
PET/MRI, Imaging technique, Cervix Cancer, FLT PET radiotracer, Response assessment, Radiation treatment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]FLT-PET/MRI body scan
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]FLT-PET/MRI body scan
Intervention Description
[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.
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)
Title
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)
Title
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)
Title
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
Title
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)
Title
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)
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 No distant metastasis in staging work up ECOG 0-2 Age 21 or over (no upper age limit) Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiattisa Sommat
Phone
64368000
Email
kiattisa.sommat@singhealth.com.sg
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiattisa S Sommat
Phone
64368000
Email
kiattisa.sommat@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Novel Functional Imaging Technique With FLT-PET/MRI For Staging, Response Assessment and Radiation Treatment Planning in Cervix Cancer

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