Skip to main content
OpenTrials
Completed

NCT Number: NCT01759355

Hybrid PET/MR in the Therapy of Cervical Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FDG PET/MR

Procedure

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

Other names: FDG Positron Emission Tomography/Magnetic Resonance Scan

Primary outcomes

  1. Proportion of patients who successfully complete PET/MR scans at all study time-points

    Time frame: 2-3 months post-treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

Hybrid PET/MR in the Therapy of Cervical Cancer: A Pilot Study

Important dates

Study start
2012
Primary completion
2020
Study completion
2020
First posted
Jan 3, 2013
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.