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

NCT ID: NCT05355558

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2022-12-31

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.

Conditions

Image, Body; Cervix Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[18F]FLT-PET/MRI body scan

Group Type: EXPERIMENTAL

[18F]FLT-PET/MRI body scan

Intervention Type: DIAGNOSTIC_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.

Interventions

[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.

Intervention Type: DIAGNOSTIC_TEST

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)

• 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.

Exclusion Criteria

• Patients scheduled for neoadjuvant chemotherapy
• Patients with previous hysterectomy or radiotherapy to the pelvis
• Patients who are pregnant or lactating

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Cancer Centre Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Singapore

Central Contacts

Kiattisa Sommat

Role: CONTACT

kiattisa.sommat@singhealth.com.sg

64368000

Facility Contacts

Kiattisa S Sommat

Role: primary

kiattisa.sommat@singhealth.com.sg

64368000

Other Identifiers

LEGEND19

Identifier Type: -

Identifier Source: org_study_id