NCT02651246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

June 24, 2021

Status Verified

June 1, 2021

Enrollment Period

4.2 years

First QC Date

January 6, 2016

Last Update Submit

June 21, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Number of tumor recurrence

    2 years

Interventions

data collectionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cancer patients who undergo surgery and intraoperative imaging

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Thyroid DiseasesNeoplasmsDesmoid Tumors

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Endocrine System DiseasesFibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Sunil Singhal, MD, Ph.D

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

December 1, 2015

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

June 24, 2021

Record last verified: 2021-06

Locations

US(1)