NCT02441062

Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Sue O'Dorisio · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors. The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.

Detailed description

This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.

Conditions

• Neuroendocrine Tumors
• Carcinoid Tumors
• Neuroblastoma
• Medulloblastoma

Interventions

Type	Name	Description
DRUG	68Ga-DOTATOC PET/CT	Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors

Timeline

• Start date: 2015-09-01
• Primary completion: 2020-01-20
• Completion: 2020-01-20
• First posted: 2015-05-12
• Last updated: 2020-12-21
• Results posted: 2020-12-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study