RightFit
RecruitingPhase 1 / Phase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years
  • Procedures mentioned: MRI scans, CT scans, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the side effects and how well a light-activated drug helps surgeons find cancer and kill cancer cells with laser light during surgery. It is for adults having surgery for colon or rectal cancer that has spread nearby or come back. The study is now in Phase 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older.
  • Have colon or rectal cancer that has spread to nearby tissue or lymph nodes, or has come back, and be having surgery.
  • Be able to have CT and MRI scans.
  • Have a daily activity score (ECOG) of 0 to 3, which allows some limits in activity and self-care.
  • If you can become pregnant, agree to use birth control or avoid sex before joining. Tell your doctor right away if you or your partner becomes pregnant or may be pregnant during the study.
  • Understand that the treatment is being studied and sign a consent form before any study procedures.

Who can't join

  • Be pregnant or breastfeeding.
  • Have porphyria, a disorder involving chemicals the body uses to make blood, or a known allergy to porphyrins or similar chemicals.
  • Not be cleared to have surgery.
  • Have sudden liver inflammation (acute hepatitis), or long-term liver problems with AST or ALT blood test levels at least 2.5 times the upper normal limit.
  • Have an uncontrolled illness, such as an active infection, heart failure with symptoms, unstable chest pain, or an abnormal heartbeat.
  • Have a mental health condition or life situation that would keep you from following study rules.
  • Be unwilling or unable to follow study rules.
  • Have any condition that the study doctor thinks makes the study drug, surgery, or light treatment unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study sites (1)

NY