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Hybrid PET/MR in the Therapy of Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01759355
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : December 3, 2021
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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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
Actual Study Start Date : October 2012
Actual Primary Completion Date : May 28, 2020
Actual Study Completion Date : May 28, 2020

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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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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759355


Locations
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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
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Principal Investigator: Jorge Oldan, MD University of North Carolina, Chapel Hill
More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01759355    
Other Study ID Numbers: LCCC1221
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: December 2021
Additional relevant MeSH terms:
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Carcinoma
Uterine Cervical Neoplasms
Carcinoma, Adenosquamous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
 Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Complex and Mixed