Clinical trial NCT05355558: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Image, Body
Cervix Cancer
Keywords: PET/MRI
Imaging technique
Cervix Cancer
FLT PET radiotracer
Response assessment
Radiation treatment
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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* Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice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.

Primary outcomes:
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
timeFrame: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Secondary outcomes:
measure: Compare SUV uptake of FLT with FDG PET at diagnosis
timeFrame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
measure: Compare SUV uptake of FLT before and after chemoRT
timeFrame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
measure: 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
timeFrame: Baseline (1 to 28 days before prior initiation of radiotherapy) and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
measure: 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
timeFrame: Through patient treatment completion, an average of 3 months
measure: Compare changes in stimulated radiation treatment volume when derived from PET/MRI vs PET/CT vs MRI
timeFrame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
measure: Compare VMAT versus IMRT versus proton versus tomotherapy for best marrow sparing plan
timeFrame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
measure: To determine the correlation of [18F]FLT parameters as baseline, during treatment and change in [18F] FLT parameters with clinical outcome and response
timeFrame: Baseline, 1 to 28 days before prior initiation of radiotherapy and Week 4 - 5 of External Beam Radiotherapy (before brachytherapy)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
References: