NCT04219904

Brief Summary

This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
17mo left

Started Sep 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress85%
Sep 2018Sep 2027

Study Start

First participant enrolled

September 7, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

9.1 years

First QC Date

December 30, 2019

Last Update Submit

November 17, 2025

Conditions

Stage IA Cervical CancerStage IA1 Cervical CancerStage IA2 Cervical CancerStage IB Cervical CancerStage IB1 Cervical CancerStage IB2 Cervical CancerStage IB3 Cervical Cancer

Outcome Measures

Primary Outcomes (1)

  • Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)

    Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.

    3 years

Secondary Outcomes (3)

  • Assessing the Lymph node involvement by PET/MRI

    3 years

  • Inter-observer variability of PET/MR

    3 years

  • Quantitative imaging parameters of the tumor

    3 years

Study Arms (1)

Diagnostic (PET/MRI)

EXPERIMENTAL

Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.

Other: Fludeoxyglucose F-18Drug: GadobutrolProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Interventions

Fludeoxyglucose F-18OTHER

Given IV

Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Diagnostic (PET/MRI)
GadobutrolDRUG

Given IV

Also known as: BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
Diagnostic (PET/MRI)
Magnetic Resonance ImagingPROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, nuclear magnetic resonance imaging
Diagnostic (PET/MRI)
Positron Emission TomographyPROCEDURE

Undergo PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (PET/MRI)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors \> 4 cm
  • No contraindications to MRI
  • Patients undergoing surgical procedure at MD Anderson
  • Suspected cervical cancer

You may not qualify if:

  • Patients who have contraindication to MRI
  • Glomerular filtration rate (GFR) \< 30
  • Pregnant patients
  • Patients with history of previous radiation
  • Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
  • Patients with endometrial cancer extending to the cervix
  • Allergic reaction to gadolinium based contrast
  • Body weight of greater than 450 (181.4 kg)
  • Patients requiring general sedation
  • Extremely claustrophobic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Fluorodeoxyglucose F18gadobutrolMagnetic 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

  • Sanaz Javadi

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2019

First Posted

January 7, 2020

Study Start

September 7, 2018

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

US(1)