GA-68 DOTA-TOC of Somatostatin Positive Malignancies

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Neuroblastoma; Carcinoid Tumors; Paraganglioma; Neuroendocrine Tumor

Treatments: Drug: Gallium Ga 68-Edotreotide; Procedure: Computed Tomography (CT); Procedure: Positron Emission Tomography (PET); Procedure: Magnetic Resonance Imaging (MRI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02177773

NCI-2017-00451 (Registry Identifier)

14453-HDFCCC

Details and patient eligibility

About

This phase I/II trial studies how well gallium Ga 68-DOTA-TOC positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) works in imaging patients with somatostatin receptor positive tumors. Gallium Ga 68-DOTA-TOC binds to somatostatin receptor positive tumors and can be seen using a PET scan. A PET scan uses a special camera to detect energy given off from gallium Ga 68-DOTA-TOC, to make detailed pictures of areas where material accumulates in the body. Diagnostic procedures, such as gallium Ga 68-DOTA-TOC PET/CT or PET/MRI, may help find and diagnose somatostatin receptor positive tumors and help plan the best treatment.

Full description

PRIMARY OBJECTIVES:

I. To determine if gallium Ga 68-DOTA-TOC (gallium-68 labeled DOTA-TOC) results in the delineation of more lesions than with conventional imaging.

SECONDARY OBJECTIVES:

I. To determine if the incorporation of gallium (Ga)-68 DOTA-TOC PET/CT into the management decision making process results in a change in stage of the patient.

OUTLINE:

Patients receive gallium Ga 68-DOTA-TOC intravenously (IV) over 1-2 minutes. Within 55-70 minutes, patients then undergo a PET/CT scan over 30-40 minutes or a PET/MRI scan over 50 minutes.

After completion of study, patients are followed up for 2 weeks.

Enrollment: 300 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
• Age > 1.
• Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) equivalent).
• Not pregnant. A negative serum pregnancy test is required for all female subjects with childbearing potential.
• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

• Hepatic enzymes 5 times greater than the upper limits of normal, serum creatinine > 3.0 mg/dL (270 Micromole per liter (uM/L).
• Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET /CT scanner due to BMI
• Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol.
• Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
• Recognized concurrent active infection Previous systemic or radiation treatment for another cancer of any type within the last 2 months.
• Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

300 participants in 1 patient group

Ga-68 DOTA-TOC PET/CT

Experimental group

Description:

Patients receive Gallium Ga 68-DOTA-TOC IV over 1-2 minutes. Within 55-70 minutes, patients then undergo either a PET/CT scan lasting 30-40 minutes or a PET/MRI scan lasting 50 minutes.

Treatment:

Procedure: Magnetic Resonance Imaging (MRI)

Procedure: Positron Emission Tomography (PET)

Procedure: Computed Tomography (CT)

Drug: Gallium Ga 68-Edotreotide