Clinical Trial · NCT03136328

Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

Overview

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

Sponsor

Tufts Medical Center

Phase

Phase 3

Contacts

Charito Love, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03136328

Drug / Compound

DOTATOC

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
Platelets: \>50x109/L
Recent Blood test results up to 4-6 weeks as follows:
A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
White Blood Cell (WBC): \>2\*109/L
Histologically and/or clinically confirmed and/or suspicious of NET.
Bilirubin less than, or equal to, three times its ULN
Karnofsky status ≥60.
Haemoglobin: \>8.0g/Dl

Exclusion

Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.