Status:

RECRUITING

68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

Lead Sponsor:

University of Alberta

Conditions:

Neuroendocrine Tumors

Eligibility:

All Genders

Phase:

PHASE2

Brief Summary

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has b...

Detailed Description

A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin rec...

Eligibility Criteria

Inclusion

  • Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
  • A standard clinical CT or MRI is obtained within 6 months of enrollment
  • Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

Exclusion

  • Weight \> 225 kg (weight limit of the PET/CT scanner)
  • Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
  • Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
  • Previous allergic reaction to DOTATATE or somatostatin analogues
  • Lack of intravenous access

Key Trial Info

Start Date :

February 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 31 2028

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT04888481

Start Date

February 15 2022

End Date

August 31 2028

Last Update

May 7 2025

Active Locations (1)

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1

University of Alberta

Edmonton, Alberta, Canada, T6G 2B7

68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors | DecenTrialz