Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Part of paid clinical trials in Duarte, California.

Sponsor
Surgimab
Study ID
NCT03659448
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SGM-101 — DRUG
    A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.

Study Details

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.

Key Dates

Start date
Jun 17, 2019
Status verified
Apr 2024
Primary completion
Nov 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Treatment
    Patients will receive a single dose of the study drug, SGM-101, and subsequently undergo surgical resections under both "standard "white light" conditions and then NIR.
  • No Intervention: No Treatment
    Patients will not be administered the study drug, SGM-101, and will undergo surgical resections under standard :white light" conditions only.

Primary Outcome Measure

Surgical resection histopathology. [ Time Frame: Through completion of surgery, up to 9 weeks. ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Thinzar Lwin, MD, MS
[email protected]
626-613-6032
Thinzar Lwin, MD, MS (PRINCIPAL_INVESTIGATOR)
Moores Cancer Center - UCSD HealthLa JollaCalifornia92093
Sonia L Ramamoorthy, MD
[email protected]
858-657-6100
Dad Shakeela, Ph.D.
[email protected]
(858) 822-5376
Sonia L Ramamoorthy, MD (PRINCIPAL_INVESTIGATOR)
Andrew Lowy, MD (SUB_INVESTIGATOR)
Joel Baumgartner, MD (SUB_INVESTIGATOR)
Rebekah White, MD (SUB_INVESTIGATOR)
Kaitlyn Kelly, MD (SUB_INVESTIGATOR)
Jason Sicklick, MD (SUB_INVESTIGATOR)
Nicole Lopez, MD (SUB_INVESTIGATOR)
Jula Veerapong, MD (SUB_INVESTIGATOR)
Samuel Eisenstein, MD (SUB_INVESTIGATOR)
Cleveland Clinic FloridaWestonFlorida33331
David J MARON, MD
[email protected]
954-659-5278
Maria MEJIA, BS, CCRP
[email protected]
(954) 659-5888
David J Maron, MD (PRINCIPAL_INVESTIGATOR)
Steven Wexner, MD (SUB_INVESTIGATOR)
Eric Weiss, MD (SUB_INVESTIGATOR)
Giovanna DaSilva, MD (SUB_INVESTIGATOR)
Dana Sands, MD (SUB_INVESTIGATOR)
Conrad Simpfendorfer, MD (SUB_INVESTIGATOR)
Mayank Roy, MD (SUB_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Rocco Ricciardi, MD
[email protected]
Caitlin Stafford
[email protected]
617-643-7869
Rocco Ricciardi, MD (PRINCIPAL_INVESTIGATOR)
Horoko Kunitake, MD (SUB_INVESTIGATOR)
Richard Hodin, MD (SUB_INVESTIGATOR)
Liliana Bordeianou, MD (SUB_INVESTIGATOR)
University of MassachusettsWorcesterMassachusetts01655
Sharon Balcom, RN
[email protected]
508-334-4918
Karim Alavi, MD (PRINCIPAL_INVESTIGATOR)
Perelman Center for Advanced MedicinePhiladelphiaPennsylvania19104
Sunil Singhal, MD
[email protected]
Najjia Mahmoud, MD (SUB_INVESTIGATOR)
Sunil Singhal, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
City of Hope National Medical Center· Duarte, CAMoores Cancer Center - UCSD Health· La Jolla, CACleveland Clinic Florida· Weston, FLMassachusetts General Hospital· Boston, MAUniversity of Massachusetts· Worcester, MAPerelman Center for Advanced Medicine· Philadelphia, PA

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