Hybrid PET/MR in the Therapy of Cervical Cancer

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UNC Lineberger Comprehensive Cancer Center

Status

Completed

Conditions

Cervical Adenosquamous Carcinoma
Cervix Carcinoma
Cervical Squamous Cell Carcinoma

Treatments

Procedure: FDG PET/MR

Study type

Observational

Funder types

Other

Identifiers

NCT01759355
LCCC1221

Details and patient eligibility

About

This is a two arm, single center feasibility study of 20 patients with non-metastatic cervical cancer managed with surgery and/or chemoradiation therapy at UNC Hospitals. Subjects will undergo PET/MRI scans before, during (chemoradiation group only), and after treatment.

Full description

The primary purpose of this study is to evaluate the feasibility of obtaining complete and interpretable hybrid PET/MR images for patients diagnosed with cervical cancer.

Enrollment

18 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years of age
  • Biopsy-proven, previously untreated squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the uterine cervix
  • Clinically visible lesion at least FIGO stage Ib or AJCC 7th edition T1b
  • Scheduled to undergo standard of care PET/CT for baseline assessment of disease
  • Anticipated to be eligible for curative intent therapy (surgery of chemoradiation therapy) as determined by the patient's primary oncologist
  • If female of child-bearing potential, negative serum or urine pregnancy test ≤ 7 dats prior to first PET/MRI
  • Informed consent reviewed and signed

Exclusion criteria

  • History of sever reaction to contrast-enhanced CT scan
  • Inability to tolerate MRI (e.g., inability to lie flat > 1 hour)
  • Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
  • Poorly controlled diabetes mellitus
  • Creatinine > 1.4 mg/dL or GFR < 30 mL/min
  • Body Mass Index (BMI) > 35
  • Active vaginal bleeding requiring packing and emergent radiation therapy
  • Pregnant or lactating female
  • History of a prior malignancy within past 5 years, unless disease free for ≥ 3 years
  • Substance abuse, medical, psychological, or social conditions that may interfere with study participation

Trial design

18 participants in 2 patient groups

Surgery
Description:
Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans.
Treatment:
Procedure: FDG PET/MR
Chemoradiation
Description:
Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans.
Treatment:
Procedure: FDG PET/MR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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