NCT01759355

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

7.7 years

First QC Date

December 17, 2012

Last Update Submit

December 2, 2021

Conditions

Cervix CarcinomaCervical Squamous Cell CarcinomaCervical Adenosquamous Carcinoma

Outcome Measures

Primary Outcomes (1)

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

    2-3 months post-treatment

Secondary Outcomes (4)

  • Sensitivity of PET/MR for baseline disease assessment

    pre-treatment

  • Specificity of hybrid PET/MR for baseline disease assessment

    pre-treatment

  • Accuracy of hybrid PET/MR for baseline disease assessment

    pre-treatment

  • Detection of disease with PET/MR at each time point

    pre-treatment to 2-3 months post-treatment

Study Arms (2)

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

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

Interventions

FDG PET/MRPROCEDURE

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

Also known as: FDG Positron Emission Tomography/Magnetic Resonance Scan
ChemoradiationSurgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

UNC Hospitals

You may qualify if:

  • ≥ 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jorge Oldan, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2012

First Posted

January 3, 2013

Study Start

October 1, 2012

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

December 3, 2021

Record last verified: 2021-12

Locations

US(1)