PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00003429

First received: November 1, 1999

Last updated: February 6, 2009

Last verified: March 2003

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

May 1998

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00003429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

Official Title ^ICMJE

A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer

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.

Detailed Description

OBJECTIVES:

Assess the feasibility of using fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in patients with primary or recurrent cervical cancer.
Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients.
Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers.
Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer.
Investigate the ability of FDG-PET to identify recurrent cervical cancer.

OUTLINE: This is a diagnostic study.

Patients with primary cervical cancer receive fludeoxyglucose F 18 (FDG) intravenously followed 45 minutes later with positron emission tomography (PET) imaging over 60 minutes, as well as computed tomography (CT) scan. Both diagnostic imaging techniques are to assess the abdomen and pelvis, and must be done within 2 weeks prior to surgery. Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings.

Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax, abdomen, and pelvis prior to surgical exploration for pelvic exenteration. All biopsy specimens are evaluated for correlation with diagnostic tests findings.

PROJECTED ACCRUAL: A total of 30 patients (20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer) will be accrued for this study.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Primary Purpose: Diagnostic

Condition ^ICMJE

Cervical Cancer

Intervention ^ICMJE

Procedure: biopsy
Procedure: computed tomography
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00003429

Other Study ID Numbers ^ICMJE

CDR0000066454, MSKCC-98047, NCI-G98-1452

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Steven M. Larson, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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