Hybrid PET/MR in the Therapy of Cervical Cancer

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