Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
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
- Procedures mentioned: Heart tracing (ECG), Physical exams, Injections
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
- "During the pre-procedure visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed."
- "On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection."
- 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 early safety of LUM015 and how well it works with the LUM Imaging System to find cancer in tissue removed from the body. It is for adults having surgery for cancer of the colon or rectum, pancreas, or esophagus (the tube that carries food to the stomach).
The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have a biopsy showing adenocarcinoma (a cancer that starts in gland cells) in the esophagus, colon or rectum, or pancreas. Certain high-risk cell changes and cyst-like growths also qualify. Any cancer stage is allowed.
- Be scheduled to have the main tumor removed by surgery or a procedure using a scope, and be healthy enough for it.
- Past radiation or chemotherapy before surgery is allowed.
- Be willing and able to follow study instructions and sign a consent form.
- Have blood cell counts and liver and kidney test results that meet the study’s limits.
- Be fully active or able to walk and do light work, even if heavy activity is limited.
- If you can become pregnant, agree to use birth control or avoid sex from study entry until 60 days after the imaging drug injection. Tell your doctor right away if you may be pregnant.
Who can't join
- Have taken an experimental drug within 30 days before joining.
- Have a QTc over 480 milliseconds—a heart test measure of how long the heart takes to reset between beats.
- Still have side effects from medicines or test agents given more than 4 weeks ago.
- Have blood pressure that stays above 180 for the top number or 110 for the bottom number.
- Have had an allergic reaction to medicines containing polyethylene glycol (PEG), or to contrast dyes swallowed or given into a vein.
- Are pregnant or breastfeeding, or are sexually active and cannot or will not use an accepted form of birth control when joining.
- Have HIV and take a combination of medicines to treat it.
- The study doctor believes joining is not in your best interest.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled. 2. Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy. 3. Age of 18 years or older. 4. Subjects must be able and willing to follow study procedures and instructions. 5. Subjects must have received and signed an informed consent form. 6. Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure. 7. Subjects must have normal organ and marrow function as defined below: * Leukocytes \>/= 3,000/mcL * Absolute neutrophil count \>/= 1,500/mcL * Platelets \>/= 100,000/mcL * total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction) * AST (SGOT)/ALT (SGPT) \</= 2.5 X institutional upper limit of normal (\</= 5 x ULN in cases of malignant biliary obstruction) * Creatinine within normal institutional limits or creatinine clearance \>/= 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. 8. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 9. Subjects with ECOG performance status of 0 or 1. Exclusion Criteria: 1. Subjects who have taken an investigational drug within 30 days of enrollment. 2. Subjects with QTc interval \> 480ms. 3. Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier. 4. Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy 5. History of allergic reaction attributed to drugs containing polyethylene glycol (PEG) 6. History of allergic reaction to oral or intravenous contrast agents. 7. Pregnant women or lactating women 8. Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study. 9. HIV-positive individuals on combination antiretroviral therapy. 10. Any subject for whom the investigator feels participation is not in the best interest of the subject.
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Andrew Chan, MD, Ph.D · Study contactMore trials in Boston