NCT01869725

Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Sue O'Dorisio · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Detailed description

PRIMARY OBJECTIVES: I. To compare efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors. OUTLINE: Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

Conditions

• Adult Medulloblastoma
• Childhood Medulloblastoma
• Neuroblastoma
• Neuroendocrine Tumor
• Somatostatinoma

Interventions

Type	Name	Description
DRUG	gallium Ga 68-edotreotide	Given IV
PROCEDURE	positron emission tomography/computed tomography	Undergo gallium Ga 68-edotreotide PET/CT scan
RADIATION	indium In 111 pentetreotide	Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
PROCEDURE	computed tomography	Undergo indium In 111 pentetreotide contrast-enhanced CT scan
PROCEDURE	contrast-enhanced magnetic resonance imaging	Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan

Timeline

• Start date: 2013-04-01
• Primary completion: 2018-12-26
• Completion: 2018-12-26
• First posted: 2013-06-05
• Last updated: 2021-09-22
• Results posted: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study