Hybrid PET/MR in the Therapy of Cervical Cancer

Completed

• Conditions: Cervical Squamous Cell Carcinoma; Cervical Adenosquamous Carcinoma; Cervix Carcinoma
• Interventions: Procedure: FDG PET/MR

• Registration Number: NCT01759355
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-30
• Study First Posted: 2013-01-03
• Primary Completion: 2020-05-28
• Study Completion: 2020-05-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients who successfully complete PET/MR scans at all study time-points	2-3 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Specificity of hybrid PET/MR for baseline disease assessment	pre-treatment	Proportion of subjects without disease (negative pathology or PET/CT) that have negative PET/MR scans.
Sensitivity of PET/MR for baseline disease assessment	pre-treatment	Estimated proportion of subjects with disease (positive pathology or PET/CT) that have positive PET/MR scans.
Accuracy of hybrid PET/MR for baseline disease assessment	pre-treatment	Proportion of correct assessments among total population
Detection of disease with PET/MR at each time point	pre-treatment to 2-3 months post-treatment

Trial Locations

Locations (1)

University of North Carolina-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States