Hybrid PET/MR in the Therapy of Cervical Cancer

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Cervix Carcinoma; Cervical Squamous Cell Carcinoma; Cervical Adenosquamous Carcinoma	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 Design

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Study Type :	Observational
Actual Enrollment :	18 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
Study Start Date :	October 2012
Actual Primary Completion Date :	November 2014
Estimated Study Completion Date :	May 2018

Groups and Cohorts

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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 Name: 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 Name: FDG Positron Emission Tomography/Magnetic Resonance Scan

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Proportion of patients who successfully complete PET/MR scans at all study time-points [ Time Frame: 2-3 months post-treatment ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

UNC Hospitals

Criteria

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

Investigators

Principal Investigator:	Jorge Oldan, MD	University of North Carolina, Chapel Hill

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01759355 History of Changes
Other Study ID Numbers:	LCCC1221
First Posted:	January 3, 2013
Last Update Posted:	May 3, 2017
Last Verified:	May 2017

Additional relevant MeSH terms:

Carcinoma; Carcinoma, Squamous Cell; Uterine Cervical Neoplasms; Carcinoma, Adenosquamous; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell	Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Neoplasms, Complex and Mixed