Hybrid Pet/MR in the Therapy of Cervical Cancer
This study is currently recruiting participants.
Verified February 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01759355
First received: December 17, 2012
Last updated: February 19, 2013
Last verified: February 2013
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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: | October 2016 |
| Estimated Primary Completion Date: | October 2013 (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
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: | February 19, 2013 |
| 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 May 23, 2013