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Efficacy of Gamma Camera Used Intraoperatively for ID of Sentinel Lymph Nodes w/ Lymphoscintigraphy

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ClinicalTrials.gov Identifier: NCT01314963
Recruitment Status : Completed
First Posted : March 15, 2011
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Collaborator:
Whitaker Foundation
Information provided by (Responsible Party):
John B. Sunwoo, Stanford University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Multiple Myeloma
Breast Cancer
Interventions: Device: Prototype intraoperative handheld gamma camera (pIHGC)
Device: Lymphoscintigraphy with intraoperative gamma probes (GP)
Radiation: radioactive Tc99M

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Participants This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.

Participant Flow:   Overall Study
    All Participants
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The required data for baseline results is participant-level data. This study is a comparison of lesion-level data sets, ie, a comparison of intra-participant data. It is not possible to segregate participant baseline data to one group or the other of the intra-participant datasets.

Reporting Groups
  Description
All Participants This study evaluates the ability of 2 procedures to detect sentinel lymph nodes (SLNs), and does not evaluate between groups of participants.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
18 years old or greater   50 
[1] All available information on age is provided. Some data are missing, specifically whether or not certain participants were older or younger than age 65. Therefore the number of participants 18 to 65 vs the number of participants older than 65 is not available.
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      27  54.0% 
Male      23  46.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      0   0.0% 
Unknown or Not Reported      50 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      0   0.0% 
More than one race      0   0.0% 
Unknown or Not Reported      50 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   50 


  Outcome Measures

1.  Primary:   Relative Node Detection Sensitivity   [ Time Frame: 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Craig Levin, PhD; Professor of Radiology (Molecular Imaging Program at Stanford/Nuclear Medicine)
Organization: Stanford Univeristy Medical Center
phone: 650-736-0449
e-mail: cslevin@stanford.edu


Publications of Results:

Responsible Party: John B. Sunwoo, Stanford University
ClinicalTrials.gov Identifier: NCT01314963     History of Changes
Other Study ID Numbers: IRB-06037
SU-03092011-7560 ( Other Identifier: Stanford University )
MEL0004 ( Other Identifier: OnCore )
First Submitted: March 11, 2011
First Posted: March 15, 2011
Results First Submitted: February 22, 2018
Results First Posted: April 30, 2018
Last Update Posted: April 30, 2018