NCT00003429

Brief Summary

RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the ability to detect cancer or recurrence of cancer. PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1998

Longer than P75 for not_applicable

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

May 1, 1998

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

4.4 years

First QC Date

November 1, 1999

Last Update Submit

December 17, 2015

Conditions

Cervical Cancer

Keywords

stage I cervical cancerstage II cervical cancerrecurrent cervical cancer

Interventions

biopsyPROCEDURE
computed tomographyPROCEDURE
positron emission tomographyPROCEDURE
fludeoxyglucose F 18RADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Must meet one of the following criteria: * Histologically confirmed primary invasive squamous carcinoma or adenocarcinoma of the cervix * History of cervical cancer suspected of being recurrent * Known diagnosis of recurrent cervical cancer being considered for pelvic exenteration PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No insulin-dependent diabetes mellitus * No active serious infection not controlled by antibiotics * Must tolerate being in the scanner for the duration of the study * Not mentally retarded * No prisoners * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

BiopsyMagnetic Resonance SpectroscopyFluorodeoxyglucose F18

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)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesSpectrum AnalysisChemistry Techniques, AnalyticalDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Steven M. Larson, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

May 1, 1998

Primary Completion

October 1, 2002

Study Completion

October 1, 2002

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(1)