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PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
iodinated contrast dye
computed tomography
positron emission tomography
fludeoxyglucose F 18
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 10, 1999
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004152
Brief Title
PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Diagnostic procedures may improve the ability to detect metastatic melanoma and to determine the extent of disease. PURPOSE: Phase II trial to evaluate the effectiveness of PET and CT scans to detect metastatic disease in patients who have stage III or stage IV melanoma.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
iodinated contrast dye
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary S. Brady, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma

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