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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT01980732
Eligibility Criteria:
Inclusion Criteria:
* Greater than 18 years-old at the time of radiotracer administration
* Provides written informed consent
* Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
* Karnofsky score greater than 50 or ECOG Performance Status 0-2
* Women of childbearing age must have a negative pregnancy test at screening/baseline
* Able to remain still for duration of each imaging procedure (about one hour)
Exclusion Criteria:
* Less than 18 years-old at the time of radiotracer administration
* Pregnant or nursing
* Serum creatinine \>3.0 mg/dL
* Hepatic enzyme levels more than 5 times upper limit of normal.
* Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01980732
Study Brief:
Protocol Section:
NCT01980732