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Photosensitizing Agent

Treatment (aminolevulinic, fluorescence-guided surgery, PDT) for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Led By Anthony S Dakwar

Research Sponsored by Roswell Park Cancer Institute

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 up to 3 years

Awards & highlights

Study Summary

This trial aims to study the use of a drug called aminolevulinic acid hydrochloride in combination with a special type of surgery called fluorescence image guided surgery followed by intraoperative photodynamic

Who is the study for?

This trial is for patients with colorectal cancer that has spread to nearby areas or returned after treatment. Participants should be suitable for surgery and photodynamic therapy, but specific inclusion and exclusion criteria are not provided.Check my eligibility

What is being tested?

The study tests a two-step treatment: first, surgeons use a special drug (aminolevulinic acid) that makes cancer cells glow under blue light during surgery; then they apply red laser light to kill any remaining cancer cells using photodynamic therapy.See study design

What are the potential side effects?

Potential side effects may include skin sensitivity to light due to the photosensitizing agent used in the procedure, as well as typical risks associated with surgical interventions and photodynamic therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Accuracy of the fluorescence imaging (Phase I)

Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II)

Evidence of disease (Phase II)

+1 more

Secondary outcome measures

Changes in CEA and ctDNA (Phase I)

Correlation between disease free survival and changes in levels of CEA (Phase II)

Correlation between disease free survival and changes in levels of ctDNA (Phase II)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (aminolevulinic, fluorescence-guided surgery, PDT)Experimental Treatment7 Interventions

Patients receive aminolevulinic acid PO 2 to 4 hours prior to SOC surgery. Patients then undergo image-guided fluorescence 5-10 minutes post surgery, and intraoperative PDT 15-45 minutes post surgery. Patients also undergo CT or MRI during screening and on follow up. Patients also undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Photodynamic Therapy

2014

Completed Phase 4

~460

Aminolevulinic Acid

2015

Completed Phase 4

~430

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Fluorescence-Guided Surgery

2016

N/A

~70

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Surgical Procedure

2020

Completed Phase 2

~160

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH

322 Previous Clinical Trials

401,498 Total Patients Enrolled

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

31,086 Total Patients Enrolled

Anthony S DakwarPrincipal InvestigatorRoswell Park Cancer Institute

Frequently Asked Questions

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

What is the primary goal of conducting this clinical trial?

"The objective of this trial, spanning up to 3 years, is to demonstrate disease response (Phase II). Secondary endpoints include assessing the recurrence rate (Phase I) using standard imaging techniques like CT and/or MRI. This will involve calculating the exact proportion of recurrences along with a 95% confidence interval. Additionally, evaluating the local recurrence rate (Phase II) through similar imaging methods aims at determining accurate proportions within a confidence interval. Lastly, monitoring changes in CEA and ctDNA levels (Phase I) involves analyzing blood samples for mean alterations from baseline alongside constructing a 95% confidence interval around these changes."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"As per clinicaltrials.gov, the ongoing study posted on 4/1/2024 and last updated on 3/5/2024 is not actively seeking participants. However, amidst a pool of 4187 active trials recruiting patients currently, this particular trial stands paused in terms of participant recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

2024. "Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06307548.

All > Photodynamic Therapy