Hybrid PET/MR in the Therapy of Cervical Cancer

Cervical Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759355
• Other study ID #: LCCC1221
• Status: Completed
• Start date: October 2012
• Est. completion date: May 28, 2020

Study information

• Verified date: December 2021
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Adenosquamous
• Cervical Adenosquamous Carcinoma
• Cervical Squamous Cell Carcinoma
• Cervix Carcinoma
• Uterine Cervical Neoplasms

Intervention

Procedure:
• FDG PET/MR
Participants will undergo a FDG, gadolinium enhanced PET/MR scan.

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who successfully complete PET/MR scans at all study time-points		2-3 months post-treatment
Secondary	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
Secondary	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
Secondary	Accuracy of hybrid PET/MR for baseline disease assessment	Proportion of correct assessments among total population	pre-treatment
Secondary	Detection of disease with PET/MR at each time point		pre-treatment to 2-3 months post-treatment