Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
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|ClinicalTrials.gov Identifier: NCT02584244|
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Pancreatic Cancer Esophageal Cancer||Drug: LUM015 Device: LUM 2.6 Imaging Device||Phase 1 Phase 2|
The overall goal of this feasibility study is to assess the initial safety and efficacy of a novel, intravenously administered cathepsin activatable imaging probe, LUM015, in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM 2.6 Imaging Device.
All subjects will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and are scheduled for resection of their primary tumors.
Patients will be seen by their surgeon in an office visit and undergo routine preoperative testing within four weeks of their planned surgery. During the pre-surgery 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 2-6 hours prior to surgery in the preoperative area. The patient will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit.
Patients will undergo their planned surgical resection 2-6 hours after LUM015 is administered. All the surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment. Imaged areas showing high fluorescence will be marked to guide pathology evaluation and determine whether the area contains tumor. Samples of imaged areas showing low fluorescence signal will also be evaluated by pathology to determine whether the area only contains normal tissue. After imaging, part of this tissue will be fresh frozen for correlative studies.
The patients are expected to be admitted to the hospital for the surgical procedure and remain in the hospital post-surgery as indicated and required by the surgeon per standard of care treatment. While in the hospital, the patient will be assessed for adverse events. Laboratory studies will also be performed during this time as a part of routine post-surgical care and to assess for any imaging agent related adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||March 2018|
Experimental: LUM Imaging System
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 12 patients will be recruited at the dose level that produces optimal LUM015 activity. Patients will undergo their planned surgical resection 2-6 hours after LUM015 injection. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
|Drug: LUM015 Device: LUM 2.6 Imaging Device|
- Determine optimal dose of LUM015 to be used according to tissue type based on optimal LUM015 activity in normal versus tumor tissue. [ Time Frame: 1 day ]
- Assess toxicity in patients with gastrointestinal cancers by monitoring adverse events, including clinically significant abnormalities in CBC and serum chemistry tests from injection until first post-operative visit [ Time Frame: 2 weeks ]
- Determine initial efficacy of LUM015 in labeling gastrointestinal cancers for molecular imaging by comparing imaging results with pathology. [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584244
|Contact: Jorge Ferrer, Ph.Dfirstname.lastname@example.org|
|Contact: Lori Gilmartinemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Andrew Chan, MD, Ph.D|
|Principal Investigator:||Andrew T Chan, M.D., Ph.D||Massachusetts General Hospital|