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A Pilot Study to Compare 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) Scanning in Addition to CT Scanning With CT Scanning Alone in the Pre-Operative Evaluation of Patients With Stage III and IV Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

A Pilot Study to Compare 18F-Fluorodeoxyglucose Positron Emission Tomography (PET) Scanning in Addition to CT Scanning With CT Scanning Alone in the Pre-Operative Evaluation of Patients With Stage III and IV Melanoma


OBJECTIVES: I. Evaluate the sensitivity, specificity, and accuracy of fludeoxyglucose F 18
(FDG) positron emission tomography (PET) imaging in detecting metastatic disease in patients
with stage III or IV melanoma considered for operative management based on the currently
accepted diagnostic work up including CT imaging. II. Determine how often the clinical
management of these patients is altered based on FDG PET imaging findings in addition to CT
scan results.

OUTLINE: Patients are required to fast for a minimum of 6 hours prior to positron emission
tomography (PET) imaging. Fludeoxyglucose F 18 (FDG) is administered IV over 15 minutes
followed 50-60 minutes later by whole body PET imaging. Iodinated contrast dye is
administered by IV injection and by mouth followed by CT imaging of the chest, abdomen, and
pelvis within 2 weeks of PET imaging. Whole body FDG PET imaging and CT imaging of the
chest, abdomen, and pelvis are repeated at 6 months. Initial positive PET or CT imaging
results are verified based on surgical and/or biopsy findings or clinical follow-up.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 2.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven melanoma considered for operative
management with 1 of the following: Deep primary melanoma (greater than 4 mm, stage IIIA)
Regional nodal disease (stage IIIB) Locally or regionally recurrent disease of an
extremity considered for operative resection or isolated limb perfusion with curative
intent Systemic disease considered for curative resection (stage IV)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified Other: Not pregnant or nursing Fertile patients must use effective contraception
Able to fast for 6 hours Able to lie still for positron emission tomography imaging No
second malignancy except previously treated nonmelanomatous skin cancer or carcinoma in
situ of the cervix No active infection No inflammatory disease (sarcoidosis or rheumatoid
arthritis) No allergy to shellfish or contrast dye used for CT imaging

PRIOR CONCURRENT THERAPY: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Mary S. Brady, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-004

NCT ID:

NCT00004152

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021