PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery - Full Text View

Purpose

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.

Condition	Intervention
Cervical Cancer	Drug: fludeoxyglucose F 18 Procedure: biopsy Procedure: computed tomography Procedure: positron emission tomography

MedlinePlus related topics:

Cancer Cervical Cancer Nuclear Scans

Drug Information available for:

Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 1998

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003429

Locations


United States, New York
	Memorial Sloan-Kettering Cancer Center
	New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Steven M. Larson, MD	Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000066454, MSKCC-98047, NCI-G98-1452
First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003429
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I cervical cancer

stage II cervical cancer

recurrent cervical cancer

Study placed in the following topic categories:

Genital Diseases, Female

Uterine Cervical Neoplasms

Uterine Cervical Diseases

Genital Neoplasms, Female

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Recurrence

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on December 02, 2008

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003429