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Status unknownNCT05355558Updated May 2, 2022

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

An interventional study of [18F]FLT-PET/MRI body scan in Image, Body and Cervix Cancer, sponsored by National Cancer Centre, Singapore. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2022-05-02.

Sponsored by National Cancer Centre, Singapore · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled May 2019, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
21 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Image, Body
  • Cervix Cancer

Keywords

  • PET/MRI
  • Imaging technique
  • Cervix Cancer
  • FLT PET radiotracer
  • Response assessment
  • Radiation treatment
03

In context

Uterine Cervical Neoplasms

1,883 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 15 is below the median of 100 across 1,378 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

National Cancer Centre, Singapore is the lead sponsor of 116 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    [18F]FLT-PET/MRI body scan

    Diagnostic Test: [18F]FLT-PET/MRI body scan

Interventions

  • Diagnostic test[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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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)

  7. 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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05355558
Lead sponsor
National Cancer Centre, Singapore
Responsible party
Sponsor
First posted
May 2, 2022
Start date
May 14, 2019
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
May 2, 2022

Study contacts

Kiattisa Sommat
Contact
kiattisa.sommat@singhealth.com.sg
64368000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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