NCT01992861

Brief Summary

This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
3 countries

6 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

November 5, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 14, 2014

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

7.9 years

First QC Date

November 5, 2013

Last Update Submit

June 22, 2023

Conditions

Cervical AdenocarcinomaCervical Adenosquamous CarcinomaCervical Squamous Cell Carcinoma, Not Otherwise SpecifiedCervical Undifferentiated CarcinomaRecurrent Cervical CarcinomaStage IB2 Cervical CancerStage II Cervical CancerStage IIA Cervical CancerStage IIB Cervical CancerStage III Cervical CancerStage IIIA Cervical CancerStage IIIB Cervical CancerStage IVA Cervical Cancer

Outcome Measures

Primary Outcomes (4)

  • Disease-free survival

    Up to 5 years

  • Distant metastatic rate

    Up to 5 years

  • Local control

    Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.

    Up to 5 years

  • Predictive power of the MRI and PET/CT parameters

    Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation.

    Up to 5 years

Study Arms (1)

Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)

Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks.

Procedure: Computed TomographyProcedure: Diffusion Weighted ImagingProcedure: Dynamic Contrast-Enhanced Magnetic Resonance ImagingRadiation: Fludeoxyglucose F-18Procedure: Magnetic Resonance Spectroscopic ImagingProcedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo FDG PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Diffusion Weighted ImagingPROCEDURE

Undergo DW MRI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Dynamic Contrast-Enhanced Magnetic Resonance ImagingPROCEDURE

Undergo DCE MRI

Also known as: DCE MRI, DCE-MRI, DYNAMIC CONTRAST ENHANCED MRI
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Fludeoxyglucose F-18RADIATION

Undergo FDG PET/CT

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Magnetic Resonance Spectroscopic ImagingPROCEDURE

Undergo MR spectroscopy

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, Proton Magnetic Resonance Spectroscopic Imaging
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)
Positron Emission TomographyPROCEDURE

Undergo FDG PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT)

Eligibility Criteria

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

Patients with stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, who will undergo radiation therapy for cervical cancer with curative intent.

You may qualify if:

  • Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
  • Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
  • Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
  • Patients with no prior radiation therapy to the pelvis
  • Patients with no contra-indications to magnetic resonance (MR) imaging
  • Patients must have adequate renal function: glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2; for the test-retest sub-study MRI, patients must have a GFR of \> 60 mL/min/1.73m\^2
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Patients with small cell/neuroendocrine cervical carcinoma
  • Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
  • Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR \< 30)
  • Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
  • Life expectancy of less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

University of Toronto

Toronto, Ontario, M5S 1A1, Canada

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Fluorodeoxyglucose F18Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Simon Lo

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 5, 2013

First Posted

November 25, 2013

Study Start

February 14, 2014

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

CA(1)HK(1)US(4)