68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)

• Sponsor: Lale Kostakoglu
• Information provided by (Responsible Party): Lale Kostakoglu, Icahn School of Medicine at Mount Sinai

Study Description

Brief Summary:

This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.

Condition or disease	Intervention/treatment	Phase
Neuroendocrine Tumors; Carcinoid Tumors	Drug: 68Ga-DOTATOC PET	Phase 1

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Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Safety and Efficacy Study of 68Ga-Dotatoc Positron Emission Tomography for Diagnosis for Staging, Restaging and Assessment of Response to Treatment in Somatostatin Receptor-Positive Neuroendocrine Tumors
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: January 23, 2017
• Actual Study Completion Date: January 23, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 68Ga-DOTATOC PET; patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)	Drug: 68Ga-DOTATOC PET; 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.; Other Names: [68Ga]-DOTA-tyr3-Octreotide; [68Ga]-DOTATOC

Outcome Measures

Primary Outcome Measures :

1. Change in size of lesion [ Time Frame: baseline and 1 month ]
   Change in size of lesion at 1 month as compared to baseline

Secondary Outcome Measures :

1. Incidence of new lesions [ Time Frame: baseline and 1 month ]
   Number of new lesions at 1 month as compared to baseline
2. Incidence of change in treatment [ Time Frame: baseline and 1 month ]
   Change in treatment caused by result of 68Ga-DOTATOC PET/CT at 1 month as compared to baseline
3. Incidence of previously unknown primary tumor [ Time Frame: baseline and 1 month ]
   Incidence of identification of the location of a previously unknown primary tumor at 1 month as compared to baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
• Karnofsky performance status of ≥50 (or ECOG/WHO equivalent)
• Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging
• Able to provide informed consent
• At least 18 years of age

Exclusion Criteria:

• Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential
• Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
• Medical condition uncontrolled by treatment making completion of study unlikely
• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI)
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
• Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Sponsors and Collaborators

Lale Kostakoglu

Investigators

• Principal Investigator: Lale Kostakoglu, MD, MPH; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Lale Kostakoglu, Chief of Nuclear Medicine and Molecular Imaging, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT02359500 History of Changes
• Other Study ID Numbers: GCO 14-2008
• First Posted: February 10, 2015
• Last Update Posted: May 3, 2017
• Last Verified: May 2017

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lale Kostakoglu, Icahn School of Medicine at Mount Sinai:

68Ga- DOTATOC; Diagnosis; Somatostatin Receptor-Positive Neuroendocrine Tumors

Additional relevant MeSH terms:

Neoplasms; Neuroendocrine Tumors; Carcinoid Tumor; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Somatostatin; Edotreotide; Octreotide; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Radiopharmaceuticals; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents