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Clinical Trial · NCT02038738
68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Overview
Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will be imaged with this agent and it will be compared to conventional imaging methods to determine the safety and efficacy of this radiopharmaceutical.
Sponsor
Methodist Health System
Phase
Phase 1/2
Contacts
Richard J. Campeau, M.D. (CONTACT)
504-464-8500
ClinicalTrials.gov
NCT02038738Drug / Compound
DOTATATE
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- SSTR2
Ligand Class: Peptides
Chelator: DOTA
Eligibility
Inclusion
- Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
- Females of childbearing potential must have a negative pregnancy test at screening/baseline
- Karnofsky performance score greater than 50
Exclusion
- Previous systemic or radiation treatment for another cancer of any type within the last 2 years
- 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
- Serum creatinine \> 2.0 mg/dL
- Known severe allergy or hypersensitivity to IV radiographic contrast
- Inability to complete the needed investigational 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
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
- Recognized concurrent active infection
- Hepatic enzyme levels more than 3 times upper limit of normal
- 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
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