Clinical trial NCT02177773: GA-68 DOTA-TOC of Somatostatin Positive Malignancies
Official title: Evaluation of Gallium-68 DOTA-TOC Imaging of Somatostatin Receptor Positive Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Tumor
Paraganglioma
Carcinoid Tumors
Neuroblastoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Peterson Family Foundation
First posted: 2014-06-30
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging
timeFrame: 1 day
measure: Standardized Uptake Value Maximum (SUVmax)
timeFrame: 1 day
measure: Inter-reader Variability
timeFrame: 1 day
Secondary outcomes:
measure: Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas A Hope, MD
role: PRINCIPAL_INVESTIGATOR
References: