Melanoma Clinical Trial
— MEL50Official title:
A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma
| NCT number | NCT00912730 |
| Other study ID # | 13565 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | June 1, 2009 |
| Last updated | October 20, 2009 |
| Start date | August 2008 |
| Verified date | October 2009 |
| Source | University of Virginia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
This is a single-institution pilot study seeking preliminary evidence of the usefulness of mobile gamma cameras in patients undergoing sentinel node biopsy for melanoma.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 18 years of age or older, AND - plan to go to the operating room for sentinel node biopsy using technicium-99 labeled colloid. Exclusion Criteria: - under 18 years of age, - unable to give informed consent, OR - not planned to go to operating room for sentinel node biopsy using technicium-99 labeled colloid. |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Virginia Health System | Charlottesville | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| University of Virginia |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary) | No | ||
| Secondary | sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary) | No |
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