Hybrid PET/MR in the Therapy of Cervical Cancer

Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Cervix Carcinoma
• Intervention / Treatment: Procedure: FDG PET/MR

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina-Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

UNC Hospitals

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery; Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans.	Procedure: FDG PET/MR; Participants will undergo a FDG, gadolinium enhanced PET/MR scan.; Other Names: FDG Positron Emission Tomography/Magnetic Resonance Scan
Chemoradiation; Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans.	Procedure: FDG PET/MR; Participants will undergo a FDG, gadolinium enhanced PET/MR scan.; Other Names: FDG Positron Emission Tomography/Magnetic Resonance Scan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): May 28, 2020
• Study Completion (ACTUAL): May 28, 2020

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 30, 2012
• First Posted (ESTIMATE): January 3, 2013

Study Record Updates

• Last Update Posted (ACTUAL): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Complex and Mixed; Carcinoma; Carcinoma, Adenosquamous
• Other Study ID Numbers: LCCC1221