Optional Sub-study to Intraoperative Imaging With ICG Registry

Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer Clinical Trial

Official title:

Optional Sub-study to Intraoperative Imaging With ICG Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651246
• Other study ID #: UPCC 31915
• Status: Completed
• Start date: December 2015
• Est. completion date: February 2020

Study information

• Verified date: June 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary goal of this optional sub-study is to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed.

Description:

Our objective is to collect prospective data on cancer subjects who undergo surgery and intraoperative imaging. The registry will include (but not limited to) cancer type, stage, intraoperative challenges to the surgeon, usage and results of intraoperative imaging, and recurrence surveillance.

In this protocol, subjects that receive intraoperative imaging will provide us the opportunity to record what tissues fluoresce in the operating room, and then to identify if these lesions are cancer when the histopathology is performed. Also, we will monitor any side effects or potential toxicities that may occur. This data can then be used to predict if a subject is more likely to develop a local recurrence due to missed cancer cells, metastatic lymph nodes or synchronous lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients >= 18 years of age

• Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and are at risk for recurrence.

• Good operative candidate as determined by the treating physician and/or multidisciplinary team

• Subject capable of giving informed consent and participating in the process of consent.

Exclusion Criteria:

• Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery

• Vulnerable patient populations

Related Conditions & MeSH terms

• Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer
• Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer
• Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer

Intervention

Other:
• data collection

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of tumor recurrence		2 years