Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.

• Age of 18 years or older.

• Subjects must be able and willing to follow study procedures and instructions.

• Subjects must have received and signed an informed consent form.

• Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.

• 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.

• 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.

• Subjects with ECOG performance status of 0 or 1.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Jorge Ferrer, Ph.D
jmferrr@lumicell.com
617-571-0592
Backup
Kate Smith, MPH
kate@lumicell.com
781-218-3268
Time Frame
Start Date: 2016-08-04
Estimated Completion Date: 2026-04
Participants
Target number of participants: 66
Treatments
Experimental: Patients with colorectal cancer
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Experimental: Patients with esophageal cancer
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Experimental: Pancreatic cancer patients receiving neoadjuvant chemotherapy
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Experimental: Pancreatic cancer patients not receiving neoadjuvant chemo
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Experimental: Gastric cancer patients who have received neoadjuvant therapy
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Experimental: Patients with early stage gastric cancer or precancerous lesions
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 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Lumicell, Inc.

This content was sourced from clinicaltrials.gov