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Sentinel Lymph Node Mapping for Rectal Cancer

N/A
Waitlist Available
Led By Traci Hedrick, MD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study, an average of 2.5 years
Awards & highlights

Study Summary

This trial is testing a new technique to find the sentinel lymph nodes in the rectum during surgery. If successful, it could help patients with early stage rectal cancer avoid a total rectal resection.

Who is the study for?
This trial is for adults who can consent and are having a specific minimally invasive surgery (TES) at the University of Virginia for early-stage rectal cancer or certain polyps. It's not for pregnant/breastfeeding women, prisoners, those with allergies to specific dyes/tracers used in the study, severe heart/renal disease patients, minors, or anyone unable to follow the study plan.Check my eligibility
What is being tested?
The trial is testing a technique using dyes and tracers during transanal endoscopic surgery to identify sentinel lymph nodes in rectal cancer patients. The goal is to see if this method can help determine whether cancer has spread without needing total rectal resection.See study design
What are the potential side effects?
Potential side effects may include reactions related to dye and tracer injections such as allergic responses or localized irritation. There might also be risks associated with additional surgical procedures required for node dissection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study, an average of 2.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study, an average of 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1st Phase: Detection rate of sentinel lymph node in first 6 patients
2nd Phase: Detection rate of refined protocol in identifying SLN
Secondary outcome measures
Ergonomic optimization of the protocol as measured by operative time
Ergonomic optimization of the protocol as measured by surgeon satisfaction
Location of the SLN according to pathologic analysis
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intraoperative sentinel lymph node mappingExperimental Treatment6 Interventions
Subjects will come to the OR and undergo a flexible sigmoidoscopy after induction of anesthesia and receive separate endoscopic injections of Spot (up to 5 cc), 99mTc-sulfur colloid (up to 0.5 mCi), and Indocyanine green (ICG) (1 ml). Patient will undergo the standard transanal endoscopic surgery (TES) to remove the rectal neoplasm, exposing the lymph node basin. The sentinel node(s) will be identified using a combination of the gamma probe and fluorescence imaging endoscopically, dissected out, and removed through a transanal approach.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Flexible sigmoidoscopy
2011
N/A
~70

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
756 Previous Clinical Trials
1,245,280 Total Patients Enrolled
Traci Hedrick, MDPrincipal InvestigatorUniversity of Virginia
2 Previous Clinical Trials
66 Total Patients Enrolled

Media Library

Rectal Cancer Research Study Groups: Intraoperative sentinel lymph node mapping
Rectal Cancer Clinical Trial 2023: Dissection of sentinel lymph node(s) Highlights & Side Effects. Trial Name: NCT02869152 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still available for this investigation?

"The information gathered from clinicaltrials.gov shows that this study, initially posted on August 1st 2016 and last edited on October 27th 2016, is no longer enrolling patients. Nevertheless, there are 307 other ongoing trials at present which require participants."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
Michigan
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sentinel Lymph Node Mapping in Rectal Cancer
Traci Hedrick, MD 2016. "Sentinel Lymph Node Mapping in Rectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02869152.
All > Rectal Cancer
~3 spots leftby May 2025
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