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Hybrid PET/MR in the Therapy of Cervical Cancer

NCT ID: NCT01759355

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2020-05-28

Brief Summary

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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

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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.

Conditions

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Cervix Carcinoma Cervical Squamous Cell Carcinoma Cervical Adenosquamous Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery

Participants undergoing surgical intervention will receive a PET/MR scan prior and following surgery for a total of two (2) scans.

FDG PET/MR

Intervention Type PROCEDURE

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

Chemoradiation

Participants undergoing chemoradiation intervention will receive a PET/MR scan prior, during, and following chemoradiation for a total of three (3) scans.

FDG PET/MR

Intervention Type PROCEDURE

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

Interventions

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FDG PET/MR

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

Intervention Type PROCEDURE

Other Intervention Names

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FDG Positron Emission Tomography/Magnetic Resonance Scan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Oldan, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC1221

Identifier Type: -

Identifier Source: org_study_id