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Cathepsin Activatable Fluorescent Probe

NCT ID: NCT01626066

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma Soft Tissue Sarcoma Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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LUM015

Receive single dose of LUM015 through a vein in the arm the day prior to surgery

Group Type EXPERIMENTAL

LUM015

Intervention Type DRUG

LUM015 assigned dose given once by IV push

Interventions

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LUM015

LUM015 assigned dose given once by IV push

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Society of Clinical Oncology

OTHER

Sponsor Role collaborator

David Kirsch

OTHER

Sponsor Role lead

Responsible Party

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David Kirsch

Associate Professor of Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Brian Brigman, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00035444

Identifier Type: -

Identifier Source: org_study_id