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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Virginia Health System Charlottesville Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

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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