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Locally Advanced Colorectal CarcinomaPhase 1/2NCT06307548

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

A Phase 1/2 study testing Aminolevulinic Acid, Biospecimen Collection and Computed Tomography in people with Locally Advanced Colorectal Carcinoma and Recurrent Colorectal Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

*As of June 2026- Phase I has been completed and we are now in Phase II. This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aminolevulinic Acid, Biospecimen Collection and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
30 Jul 2024to 1 Jun 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years of age
  • Patients with locally advanced or recurrent colorectal cancer undergoing surgery
  • Amenable to diagnostic CT and MR imaging
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 3
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Who cannot join

  • Pregnant or nursing female participants
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive the fluorescence-guided surgery with intraoperative PDT
  • Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds
  • Patients who are not cleared to undergo surgery
  • Patients with any acute hepatitis or chronic liver dysfunction with baseline elevated liver function tests (i.e. Aspartate transaminase (AST)/alanine transaminase (ALT) ≥ 2.5 x upper limit of normal [ULN]) will be excluded from the study
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients unwilling or unable to follow protocol requirements
  • Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug and/or procedure

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Anthony S. Dakwar, 716-845-5807, Anthony.Dakwar@RoswellPark.org

    Anthony S. Dakwar

    Recruiting

Other trials in United States

About this study

Official title: Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Loco-Regionally Advanced or Recurrent Colorectal Cancer Undergoing Surgery - Phase I/II

*As of June 2026- Phase I has been completed and we are now in Phase II. This phase I/II trial studies the side effects and how well fluorescence image guided surgery followed by intraoperative photodynamic therapy for improving local tumor control in patients with colorectal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back after a period of improvement (recurrent). Fluorescence image guided surgery uses a drug named aminolevulinic acid hydrochloride. Aminolevulinic acid hydrochloride is a photosensitizing agent, meaning that is activated by light and, is converted to another drug in cancer cells more than in normal cells. The converted drug emits fluorescence red light when activated with low power blue light. It is used to assist the surgeon to see cancer cells and small cancerous tissue that may have been missed during routine surgery. In addition to emitting fluorescence light, the converted drug in the cancer cells and tissue can be activated with red laser light to kill cancer cells. This procedure is called photodynamic therapy (PDT). Performing fluorescence image guided surgery followed by intraoperative photodynamic therapy after the surgical removal of the colorectal tumor before the surgical site will be closed may be effective and improve outcomes in patients with locally advanced or recurrent colorectal cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  • To test the accuracy of image-guided fluorescence to detect residual disease. Only residual disease will be recorded .(Phase I) - completed
  • To determine the safety of intraoperative PDT after fluorescence-guided surgery in patients with loco-regionally advanced or recurrent colorectal cancer undergoing surgery. (Phase I) - completed
  • To determine the potential efficacy of intraoperative PDT (after image-guided fluorescence surgery). (Phase II) -

SECONDARY OBJECTIVES:

  • To assess the relationship between disease free survival and changes in levels of carcinoembryonic antigen (CEA) and circulating tumor DNA (ctDNA). (Phase II)
  • To assess rate of recurrence by using standard-of-care computed tomography (CT) and/or magnetic resonance imaging (MRI). (Phase II)

OUTLINE:

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

After completion of study treatment, patients are followed up at 3 months, 24 weeks, and every 3 to 6 months for 3 years.

Being tested
Aminolevulinic Acid, Biospecimen Collection, Computed Tomography, Fluorescence-Guided Surgery, Magnetic Resonance Imaging
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aminolevulinic AcidDrug

    Also called 5-ALA, 5-Aminolaevulinic Acid, 5-Aminolevulinic Acid, Amino-Levulinic Acid

    Given PO

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Fluorescence-Guided SurgeryProcedure or surgery

    Also called Fluorescence-Guided Surgical Procedure

    Undergo fluorescence-guided surgery

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Photodynamic TherapyDrug

    Also called PDT, Photoradiation Therapy

    Undergo PDT

  • Surgical ProcedureProcedure or surgery

    Also called Operation, Surgery, Surgery Type, Surgery, NOS

    Undergo surgery

Study groups in NCT06307548
Study groupRoleWhat they receive
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)ExperimentalPatients 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.
Receives: Drug: Aminolevulinic Acid; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Fluorescence-Guided Surgery; Procedure: Magnetic Resonance Imaging; Drug: Photodynamic Therapy; Procedure: Surgical Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of the fluorescence imaging (Phase I)

    Will be determined by histopathology by examining the number of true positive fluorescence cases out of the total positive fluorescence biopsies collected in the study. This will be determined by reviewing the pathology reports. The proportion of surgical cases exhibiting a positive fluorescence signal by utilizing a simple proportion along with a 95% confidence interval.

    Measured: Up to 3 years

  2. Incidence of adverse events (Phase I)

    Will be measured by recording Gleolan administration and intraoperative photodynamic therapy (PDT) treatment related adverse events that are ≥ grade 3 with attribution of 'probable', or 'definite', according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0, that do not resolve within 7 days.

    Measured: Up to 30 days post-therapy

  3. Evidence of disease (Phase II)

    Will be assessed by standard-of-care computed tomography (CT) and/or magnetic resonance imaging (MRI). The recurrence proportion and exact 95% confidence interval will be calculated.

    Measured: At 12 weeks post treatment

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

    Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.

    Measured: Within 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment

Secondary outcomes (6)

  1. Changes in CEA and ctDNA (Phase I)

    Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.

    Measured: At 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment

  2. Rate of recurrence (Phase I)

    Will be evaluated with standard-of-care CT and/or MRI to detect evidence of disease. The recurrence proportion and exact 95% confidence interval will be calculated.

    Measured: At approximately 3 months post treatment, and during long term followup will be part (every 3 to 6 months up to 3 years)

  3. Rate of local recurrence (Phase II)

    Will be assessed by standard-of-care CT and/or MRI. The recurrence proportion and exact 95% confidence interval will be calculated.

    Measured: Within 3 years post treatment during standard of care follow ups

  4. Disease free survival (Phase II)

    Will be detected via standard-of-care CT and/or MRI during the long-term follow-up that will be part of standard of care. The recurrence proportion and exact 95% confidence interval will be calculated.

    Measured: Up to 3 years after treatment

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

    Monitoring of CEA levels in correlation with disease free survival

    Measured: At 4-6 weeks after treatment

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

    Monitoring of ctDNA levels in correlation with disease free survival

    Measured: At 4-6 weeks after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study start30 Jul 2024
  3. Primary completion1 Jun 2029 (estimated)
  4. Study completion1 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06307548
Sponsor's protocol ID
I-3670923
Other IDs
NCI-2024-01256, I-3670923, UL1TR001412
Status last verified
Oct 2026
First submitted
27 Feb 2024
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Aminolevulinic Acid, Biospecimen Collection and Computed Tomography in people with Locally Advanced Colorectal Carcinoma and Recurrent Colorectal Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of the fluorescence imaging (Phase I) (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06307548.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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