Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies (NCT03834272) | Clinical Trial Compass
CompletedPhase 1/2
Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies
United States18 participantsStarted 2019-03-18
Plain-language summary
The objective of this feasibility study is to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of a dose escalation phase to select the optimal dose.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
* Subjects must be scheduled for surgical resection.
* 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 otherwise healthy except for the diagnosis of cancer, as per the criteria listed below.
* Subjects must have normal organ and marrow function as defined as:
* Leukocytes \> 3,000/mcL
* Absolute neutrophil count \> 1,500/mcL
* Platelets \> 100,000/mcL
* total bilirubin within normal institutional limits
* AST (SGOT)/ALT (SGPT) \< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
* Subjects with ECOG performance status of 0 or 1.
Exclusion Criteria:
* Subjects who are pregnant or nursing at the time of diagnosis.
* Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
* Subjects who have taken an investigational drug within 30 days of enrollment.
* Subjects who have not recovered from adverse events due to other …
What they're measuring
1
Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology