Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide (GA-68)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Iowa
Sponsor:
Information provided by (Responsible Party):
O'Dorisio, M S, University of Iowa
ClinicalTrials.gov Identifier:
NCT01619865
First received: June 12, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. We will 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.


Condition Intervention
Neuroendocrine Tumors
Carcinoid Tumors
Neuroblastoma
Medulloblastoma
Drug: 68Ga-DOTATOC PET/C

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging and Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT.

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. [ Time Frame: 1 week to 6 months ] [ Designated as safety issue: Yes ]
    We will 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment after the initial PET/CT scan (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), we will measure response to treatment.


Estimated Enrollment: 200
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 68Ga-DOTATOC PET/C
    1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
    Other Name: Gallium 68
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age greater than 2 years
  • Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Karnofsky performance status or Lansky Play Scale status of greater than 50 (or ECOG/WHO equivalent)
  • Not pregnant. A negative serum pregnancy test will be required for all female subjects with child bearing potential.

Exclusion Criteria:

Inclusion Criteria:

  • Signed informed consent
  • Age greater than 2 years
  • Known or suspected somatostatin receptor positive tumor such as carcinoid; neuroendocrine tumor; neuroblastoma; medulloblastoma; pheochromocytoma. Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Karnofsky performance status or Lansky Play Scale staus of greater than 50 (or ECOG/WHO equivalent)
  • Not pregnant. A negative serum pregnancy test will be required for all female subjects with child bearing potential.

Exclusion Criteria

  • Pregnant or lactating women
  • Patients with a body weight of 400 pounds due to 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.)
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01619865

Contacts
Contact: Sue O'Dorisio, MD 319-356-3595 sue-odorisio@uiowa.edu
Contact: Suzanne R Kieffer 319-530-8051 suzanne-kieffer@uiowa.edu

Locations
United States, Iowa
University of Iowa Health Care Recruiting
Iowa City, Iowa, United States, 52242
Contact: Suzanne R Kieffer    319-530-8051    suzanne-kieffer@uiowa.edu   
Contact: Sue O'Dorisio, MD    319-356-3595    sue-odorisio@uiowa.edu   
Principal Investigator: Sue O'Dorisio, MD         
Principal Investigator: Thomas M O'Dorisio, MD         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Sue O'Dorisio, MD University of Iowa Health Care
  More Information

No publications provided

Responsible Party: O'Dorisio, M S, Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01619865     History of Changes
Other Study ID Numbers: 201110718, 114398
Study First Received: June 12, 2012
Last Updated: June 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
GA-68
Gallium 68
GA-68 PET

Additional relevant MeSH terms:
Carcinoid Tumor
Medulloblastoma
Neuroblastoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors, Primitive
Neuroectodermal Tumors, Primitive, Peripheral
Octreotide
Edotreotide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014