Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT01626066
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01626066
Study Brief:
Protocol Section:
NCT01626066