PET-CT in the Management of Patients With Stage III or IV Metastatic Melanoma
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00828126
First received: January 13, 2009
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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 change the surgical plan in patients with metastatic melanoma.
| Condition | Intervention |
|---|---|
|
Melanoma |
Procedure: PET-CT Scan |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | PET-CT in the Management of Patients With Stage III Or IV Metastatic Melanoma Considered Candidates for Surgery: Evaluation of Additive Value Following Conventional Imaging |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Percent of patients in whom a change in surgical plan occurred based on PET-CT result [ Time Frame: Evaluation following PET-CT performed within 30 days of contrast-enhanced CT. ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | January 2009 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| PET-CT Scan |
Procedure: PET-CT Scan
Positron emission tomography-computed tomography (PET-CT) scan performed within 30 days of contrast-enhanced CT.
Other Name: PET-CT
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals over 18 years of age with metastatic melanoma (melanoma that has spread to other parts of the body) and are considered a candidate for surgery based on a contrast-enhanced computer tomography (CT) scan.
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00828126
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Yulia Bronstein, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00828126 History of Changes |
| Other Study ID Numbers: | 2008-0478 |
| Study First Received: | January 13, 2009 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Metastatic Melanoma AJCC Stage III Melanoma AJCC stage IV Melanoma PET-CT Positron Emission Tomography-Computed Tomography Contrast-enhanced Computed Tomography Scan |
CT Conventional Imaging False Positive Rate Fluorodeoxyglucose FDG Surgery |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
ClinicalTrials.gov processed this record on May 19, 2013