A Pilot Study of Intraoperative Gamma Camera Imaging During Sentinel Node Biopsy for Melanoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00912730

Acronym

MEL50

Enrollment

Registered

2009-06-03

Start date

2008-08-31

Completion date

Unknown

Last updated

2009-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

melanoma, imaging, sentinel node, biopsy

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Sensitivity of the Mobile gamma camera (MGC)for detection of sentinel nodes, compared to fixed gamma camera (primary)	—

Secondary

Measure	Time frame
sensitivity of the MGC for detection of sentinel nodes, compared to handheld gamma probe (secondary)	—

Countries

United States

Outcome results