Hybrid PET/MR in the Therapy of Cervical Cancer - Full Text View

Purpose

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	Intervention
Cervix Carcinoma Cervical Squamous Cell Carcinoma Cervical Adenosquamous Carcinoma	Procedure: FDG PET/MR


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Nuclear Scans

Genetic and Rare Diseases Information Center resources: Metaplastic Carcinoma of the Breast

U.S. FDA Resources

Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:

Proportion of patients who successfully complete PET/MR scans at all study time-points [ Time Frame: 2-3 months post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity of PET/MR for baseline disease assessment [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
Estimated proportion of subjects with disease (positive pathology or PET/CT) that have positive PET/MR scans.
Specificity of hybrid PET/MR for baseline disease assessment [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
Proportion of subjects without disease (negative pathology or PET/CT) that have negative PET/MR scans.
Accuracy of hybrid PET/MR for baseline disease assessment [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]
Proportion of correct assessments among total population
Detection of disease with PET/MR at each time point [ Time Frame: pre-treatment to 2-3 months post-treatment ] [ Designated as safety issue: No ]


Estimated Enrollment:	20
Study Start Date:	October 2012
Estimated Study Completion Date:	December 2017
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759355

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:	Julia Fielding, MD	University of North Carolina, Chapel Hill

More Information

No publications provided


Responsible Party:	UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT01759355 History of Changes
Other Study ID Numbers:	LCCC1221
Study First Received:	December 17, 2012
Last Updated:	December 29, 2014
Health Authority:	United States: Institutional Review Board United States: Data and Safety Monitoring Board

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 25, 2015