GA-68 DOTA-TOC of Somatostatin Positive Malignancies

NCT02177773 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: 14453-HDFCCCNCI-2017-00451
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumor; Paraganglioma; Carcinoid Tumors; Neuroblastoma

Outcome Measures

Primary Outcomes (3)

• Number of Lesions as Determined by Gallium Ga 68-DOTA-TOC Positron Emission Tomography (PET) Imaging

  The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded The five largest lesions will be (1 = benign, 2 = likely benign, 3 = indeterminant, 4 = likely malignant, 5 = malignant). The number of positive body regions using conventional imaging and Ga-68 DOTA-TOC PET/CT will be compared using a paired t-test (or Wilcoxon signed-rank test if the data appear to be non-normally distributed). The Wilcoxon signed-rank test will also be used to compare reader confidence of paired lesions between conventional imaging and Ga-68 DOTA-TOC PET/CT

  1 day

• Standardized Uptake Value Maximum (SUVmax)

  The 5 largest lesions in each of eight body regions (head and neck, mediastinum, lung, liver, pancreas, the remaining abdomen and pelvis, bone and lymph nodes), will be measured by size (short and long axis) as well as standardized uptake value maximum on conventional imaging and the gallium Ga 68-DOTA-TOC PET imaging. Additionally, the confidence that each lesion represents a metastasis will be recorded.

  1 day

• Inter-reader Variability

  Inter-reader variability for the number of positive regions will be compared using Kappa statistics. In all cases we will provide point estimates and 95% confidence intervals for effects along with p-values.

  1 day

Secondary Outcomes (1)

• Change in Clinical Stage as Determined by Conventional Imaging and Re-determined by Gallium Ga 68-DOTA-TOC PET Imaging

  Up to 2 weeks

Study Arms (1)

Ga-68 DOTA-TOC PET/CT

EXPERIMENTAL

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.

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

Interventions

Computed Tomography (CT) PROCEDURE

Undergo Gallium Ga 68-DOTA-TOC PET/CT

Also known as: CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, Tomography

Ga-68 DOTA-TOC PET/CT

Gallium Ga 68-Edotreotide DRUG

Given Intravenously (IV) before imaging

Also known as: Ga-68 DOTA0-Tyr3-octreotide, GALLIUM EDOTREOTIDE GA-68, Gallium Ga 68-DOTATOC

Ga-68 DOTA-TOC PET/CT

Magnetic Resonance Imaging (MRI) PROCEDURE

Undergo gallium Ga 68-DOTA-TOC PET/MRI

Also known as: Magnetic Resonance Imaging, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Ga-68 DOTA-TOC PET/CT

Positron Emission Tomography (PET) PROCEDURE

Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Proton Magnetic Resonance Spectroscopic Imaging

Ga-68 DOTA-TOC PET/CT

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Peterson Family Foundation: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Neuroendocrine Tumors; Paraganglioma; Carcinoid Tumor; Neuroblastoma

Interventions

gallium Ga 68 dotatate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Since the study agent was approved for the indication by FDA it was decided not to continue investigation and waste resources to analyze data collected to see if the agent is effective for the indication.

Results Point of Contact

• Title: Dr. Thomas Hope, MD
• Organization: Unviersity of California, San Francisco

thomas.hope@ucsf.edu

(415) 221-4810

Study Officials

• Thomas A Hope, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology and Biomedical Engineering

Study Record Dates

• First Submitted: June 25, 2014
• First Posted: June 30, 2014
• Study Start: June 23, 2014
• Primary Completion: August 7, 2017
• Study Completion: August 7, 2017
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)