NCT00004152

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.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.8 years

First QC Date

December 10, 1999

Last Update Submit

January 15, 2013

Conditions

Melanoma (Skin)

Keywords

stage III melanomastage IV melanomarecurrent melanoma

Interventions

iodinated contrast dyeDRUG
computed tomographyPROCEDURE
positron emission tomographyPROCEDURE
fludeoxyglucose F 18RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Melanoma

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Mary S. Brady, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
DIAGNOSTIC
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

February 16, 2004

Study Start

February 1, 1999

Primary Completion

December 1, 2002

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)