Status:
COMPLETED
PET-CT in the Management of Patients With Stage III or IV Metastatic Melanoma
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this clinical research study is to learn how often using a positron emission tomography-computed tomography (PET-CT) scan in addition to a standard computed tomography (CT) scan will chang...
Detailed Description
If you agree to take part in this study, you will have a PET-CT scan performed. The picture produced by this scan will be compared to a standard CT scan to see if any additional tumors can be located....
Eligibility Criteria
Inclusion
- AJCC Stage III melanoma with clinically evident (macroscopic) disease, either by physical examination or on conventional imaging, or AJCC stage IV melanoma with metastatic site(s) considered surgically resectable. The initial decision regarding surgical candidacy should be made by surgical oncologist. Patients with indeterminate CT findings that are larger than 1 cm outside of the field of the potential surgery will be also included.
- Contrast- enhanced CT of chest, abdomen and pelvis performed either at MDACC or outside of the institution should indicate surgical candidacy. Outside CT imaging studies should be of acceptable quality, as determined by the evaluating radiologist. PET-CT per protocol must be performed within 30 days from the contrast-enhanced CT.
- 3\. Age \>/= 18. All minor patients will be excluded to avoid excessive radiation dose. There is data suggesting small but statistically significant increased risk for secondary malignancy due to the cumulative dose of radiation exposure associated with diagnostic imaging. Children are most sensitive to radiation long term adverse effects. Therefore current pilot study will accrue adults only. If the result of this study will indicate potential advantage of PET-CT, this data can be weighted against radiation exposure risks to decide upon imaging strategies in pediatric patients with melanoma.
Exclusion
- Regional disease limited to an involved sentinel lymph node (occult or microscopic regional nodal metastasis).
- Availability of prior PET-CT, performed within 60 days of initial clinical appointment.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00828126
Start Date
January 1 2009
End Date
March 1 2012
Last Update
March 28 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030