TheranosticTrials.org

Clinical Trial · NCT02358018

68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial

Overview

The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.

Sponsor

Memorial Sloan Kettering Cancer Center

Contacts

Ravinder Grewal, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT02358018

Drug / Compound

DOTATOC

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
  • High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.

Exclusion

  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
  • Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
  • Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
  • 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.
  • Patients that have contraindications for 111In-pentetreotide.