Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
Multicenter, Open-label, Randomized, Controlled, Parallel Arms Clinical Study on Performance of SGM-101, a Fluorochrome-labeled Anti-CEA Monoclonal Antibody, for Delineation of Primary/Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
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
Not stated in the study description — ask the study team about visits and procedures.
- 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
The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Patients should be scheduled for curative colorectal cancer surgery of primary cT4 colon cancer or primary cT3/4 rectal cancer, recurrent colorectal cancer or peritoneal metastasized colorectal cancer. * Female patients must be of non-child-bearing potential (i.e., women with functioning ovaries who have a documented tubal ligation or hysterectomy, ovariectomy or women who are post-menopausal). Women of child-bearing potential will be included provided that they have a negative urine pregnancy test at the day of the injection and agree to practice adequate contraception for 30 days prior to administration of investigational product, and 30 days after completion of injection. Exclusion Criteria: 1. Other malignancies, either currently active or diagnosed in the last 5 years, except for adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma; 2. Primary appendiceal cancer; 3. Laboratory abnormalities defined as: * Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or Alkaline Phosphatase levels above 5 times the ULN or; * Total bilirubin above 2 times the ULN or; * Serum creatinine above 1.5 times the ULN or; * Absolute neutrophils counts below 1.5 x 109/L or; * Platelet count below 100 x 109/L or; * Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males); 4. Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections; 5. Any condition that the investigator considers to be potentially jeopardizing the patient's well-being or the study objectives.
Study sites (6)
CA
- City of Hope National Medical Center · Duarte, CA 91010Thinzar Lwin, MD, MS · Study contact · 626-613-6032 · tlwin@coh.orgThinzar Lwin, MD, MS · Principal investigatorMore trials in Duarte
- Moores Cancer Center - UCSD Health · La Jolla, CA 92093Sonia L Ramamoorthy, MD · Study contact · 858-657-6100 · sramamoorthy@ucsd.eduDad Shakeela, Ph.D. · Study contact · (858) 822-5376 · sdad@ucsd.eduSonia L Ramamoorthy, MD · Principal investigatorAndrew Lowy, MD · Sub-investigatorMore trials in La Jolla
FL
- Cleveland Clinic Florida · Weston, FL 33331David J MARON, MD · Study contact · 954-659-5278 · MAROND@ccf.orgMaria MEJIA, BS, CCRP · Study contact · (954) 659-5888 · MEJIAGM@ccf.orgDavid J Maron, MD · Principal investigatorSteven Wexner, MD · Sub-investigatorMore trials in Weston
MA
- Massachusetts General Hospital · Boston, MA 02114Rocco Ricciardi, MD · Study contact · RRICCIARDI1@mgh.harvard.eduCaitlin Stafford · Study contact · 617-643-7869 · CSTAFFORD2@partners.orgRocco Ricciardi, MD · Principal investigatorHoroko Kunitake, MD · Sub-investigatorMore trials in Boston
- University of Massachusetts · Worcester, MA 01655Sharon Balcom, RN · Study contact · 508-334-4918 · Sharon.Balcom@umassmed.eduKarim Alavi, MD · Principal investigatorMore trials in Worcester
PA
- Perelman Center for Advanced Medicine · Philadelphia, PA 19104Sunil Singhal, MD · Study contact · Sunil.Singhal@uphs.upenn.eduNajjia Mahmoud, MD · Sub-investigatorSunil Singhal, MD · Principal investigatorMore trials in Philadelphia