Clinical trial NCT01759355: Hybrid PET/MR in the Therapy of Cervical Cancer
Official title: Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Carcinoma
Cervical Squamous Cell Carcinoma
Cervical Adenosquamous Carcinoma
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UNC Hospitals

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.

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 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

Primary outcomes:
measure: Proportion of patients who successfully complete PET/MR scans at all study time-points
timeFrame: 2-3 months post-treatment
Secondary outcomes:
measure: Sensitivity of PET/MR for baseline disease assessment
timeFrame: pre-treatment
measure: Specificity of hybrid PET/MR for baseline disease assessment
timeFrame: pre-treatment
measure: Accuracy of hybrid PET/MR for baseline disease assessment
timeFrame: pre-treatment
measure: Detection of disease with PET/MR at each time point
timeFrame: pre-treatment to 2-3 months post-treatment
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jorge Oldan, MD
role: PRINCIPAL_INVESTIGATOR
References: