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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Evidence of disease (Phase II)
研究概览
简要总结
*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.
详细描述
PRIMARY OBJECTIVES:
- To test the accuracy of image-guided fluorescence to detect residual disease. (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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Fluorescence-Guided Surgery (Procedure)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Biospecimen Collection (Procedure)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Computed Tomography (Procedure)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Photodynamic Therapy (Drug)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Surgical Procedure (Procedure)
Treatment (aminolevulinic, fluorescence-guided surgery, PDT)
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.
干预措施: Aminolevulinic Acid (Drug)
结局指标
主要结局
Evidence of disease (Phase II)
时间窗: At 12 weeks post treatment
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.
Changes in carcinoembryonic antigen (CEA) and circulating tumor deoxyribonucleic acid (ctDNA) (Phase II)
时间窗: Within 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment
Will be evaluated by collecting peripheral blood samples. The mean and a 95% confidence interval will be calculated around the mean change from baseline.
Incidence of adverse events (Phase I)
时间窗: Up to 30 days post-therapy
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.
Accuracy of the fluorescence imaging (Phase I)
时间窗: Up to 3 years
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.
次要结局
- Changes in CEA and ctDNA (Phase I)(At 4 weeks prior to surgical/PDT intervention and 4-6 weeks after treatment)
- Rate of recurrence (Phase I)(At approximately 3 months post treatment, and during long term followup will be part (every 3 to 6 months up to 3 years))
- Rate of local recurrence (Phase II)(Within 3 years post treatment during standard of care follow ups)
- Disease free survival (Phase II)(Up to 3 years after treatment)
- Correlation between disease free survival and changes in levels of CEA (Phase II)(At 4-6 weeks after treatment)
- Correlation between disease free survival and changes in levels of ctDNA (Phase II)(At 4-6 weeks after treatment)