Phase 2
N=97
68Ga-DOTATATE PET Scan in Neuroendocrine Cancer
Neuroendocrine Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01396382 ↗Enrolled (actual)
97
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan — 19; 9; 50 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 68Ga-DOTATATE PET scan (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan |
19; 9; 50 | — |
| SECONDARY Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability |
— | — |
Summary
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.
Eligibility Criteria
Inclusion Criteria
- Known diagnosis of neuroendocrine tumor
- At least 18 years of age
- Able to provide informed consent
- Karnofsky score greater than 50
- Females of childbearing potential must have a negative pregnancy test at screening/baseline
Exclusion Criteria
- Serum creatinine >3.0 mg/dL (270 μM/L)
- Hepatic enzyme levels more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- 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.
- Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Recognized concurrent active infection
- Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Data sourced from ClinicalTrials.gov (NCT01396382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.