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

N

National Cancer Centre, Singapore

Status

Unknown

Conditions

Image, Body
Cervix Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05355558
LEGEND19

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

21 to 99 years old

Volunteers

No 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  • Have given written informed consent, with the understanding that consent may be withdrawn at any time without prejudice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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Kiattisa Sommat

Data sourced from clinicaltrials.gov

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