Hybrid PET/MR in the Therapy of Cervical Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01759355
First received: December 17, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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.

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.


Condition
Cervix Carcinoma
Cervical Squamous Cell Carcinoma
Cervical Adenosquamous Carcinoma

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:


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
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgery
Chemoradiation

  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

Contacts
Contact: Dorothy Riguera, BS 919-843-5420 riguera@email.unc.edu

Locations
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Dorothy Riguera, BS    919-843-5420    riguera@email.unc.edu   
Principal Investigator: Julia Fielding, MD         
Sub-Investigator: Ellen Jones, MD,PhD         
Sub-Investigator: Paola Gehrig, MD         
Sub-Investigator: Victoria Bae-Jump, MD,PhD         
Sub-Investigator: Mahesh Varia, MD         
Sub-Investigator: Amir Khandani, MD         
Sub-Investigator: William McCartney, MD         
Sub-Investigator: Nathan Sheets, MD         
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: June 17, 2014
Health Authority: United States: Institutional Review Board
United States: Data and Safety Monitoring Board

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

ClinicalTrials.gov processed this record on July 22, 2014