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Optional Sub-study to Intraoperative Imaging With ICG Registry

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ClinicalTrials.gov Identifier: NCT02651246
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment
Lung, Prostate, Breast, Colon, Pancreatic, Renal, Bladder,Thyroid, Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut) Cancer Cancer of the Ovarian, Head and Neck,GI (Foregut - Esophagus),GI (Midgut), Sarcoma Cancer Cancer of Neuro-onc, Parathyroid, Desmoid Tumors, Melanoma Cancer Other: data collection

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Optional Sub-study to Intraoperative Imaging With ICG Registry
Study Start Date : December 2015
Estimated Primary Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of tumor recurrence [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cancer patients who undergo surgery and intraoperative imaging
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02651246


Contacts
Contact: Sunil Singhal, MD, Ph.D 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sunil Singhal, MD, PhD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Sunil Singhal, MD, PhD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Sunil Singhal, MD, Ph.D Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02651246     History of Changes
Other Study ID Numbers: UPCC 31915
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Fibromatosis, Aggressive
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms