Breast Cancer Clinical Trial

Cathepsin Activatable Fluorescent Probe

Summary

Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are examined to see if cancer cells are present. This may take a few to several days. Patients tissue with positive (cancer cells present) margins may require additional therapies including surgery. The purpose of this study is to determine a safe dose of a new imaging agent (LUM015), like a fluorescent contrast agent or dye, that will show in the tumor area during surgery and may help facilitate visualization of tumor for its removal.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Diagnosis of soft tissue sarcoma and breast cancer patients scheduled for a lumpectomy or mastectomy.
Subjects must be scheduled for surgical resection of a tumor at least 1 cm in size.
Performance status of 0 or 1
Able to read, understand and sign an informed consent form
Must be able and willing to follow study procedures and instructions including a possible overnight stay before surgery
Otherwise healthy except for the diagnosis of cancer
ALT, AST, and total bilirubin within 1.5x institutional upper normal limits; and alkaline phosphatase within 2.5x institutional upper normal limits
Serum creatinine of 1.5 mg or less; creatinine clearance greater than 30 ml/min
May have previously received pre-operative external beam radiation therapy for this sarcoma

Exclusion Criteria:

Pregnant or lactating
Prolonged QT interval: corrected QT interval (QTc) > 480 msec
Insulin dependent diabetes
History of anaphylactic reactions to any drug or contrast agent
Asthma under medical management
Uncontrolled high blood pressure
Severe, active co-morbidity
Known substance addiction
Sexually active and not willing/able to use medically acceptable forms of contraception.
Obesity defined as BMI as body mass index greater than 35 kg/meter squared.
Atopy or atopic syndrome
Known AIDS
Cannot have taken an investigational drug within 30 days of coming onto this study

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01626066

Recruitment Status:

Completed

Sponsor:

David Kirsch

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

15

Study ID:

NCT01626066

Recruitment Status:

Completed

Sponsor:


David Kirsch

How clear is this clinincal trial information?

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