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Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors (GA-68)

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ClinicalTrials.gov Identifier: NCT01619865
Recruitment Status : Active, not recruiting
First Posted : June 14, 2012
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Sue O'Dorisio, University of Iowa

Brief Summary:
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. Goals are to 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), this scan will be used to 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 or disease Intervention/treatment Phase
Neuroendocrine Tumors Carcinoid Tumors Neuroblastoma Medulloblastoma Drug: 68Ga-DOTATOC PET/C Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The Octreoscan and 68Ga-DOTA-tyr3-Octreotide PET scans are read independently by two certified nuclear medicine physicians for discordant positive lesions.
Primary Purpose: Diagnostic
Official Title: Safety & Efficacy of 68Ga-DOTA-tyr3-Octreotide PET/CT in Diagnosis, Staging & Measurement of Response to Treatment in Patients With Somatostatin Receptor Positive Tumors: Comparison to Octreoscan Plus High-Resolution, Contrast Enhanced CT.
Actual Study Start Date : February 2012
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: 68Ga-DOTATOC PET/CT
68Ga-DOTATOC Positron Emission Tomography (PET) for Diagnosis, Staging, and Measurement of Response to Treatment in Somatostatin Receptor Positive Tumors
Drug: 68Ga-DOTATOC PET/C
1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
Other Name: Gallium 68



Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Age greater than or equal to 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)
  • Subject is male; or is a female who is either pre-menarchal, surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), non-lactating, or of childbearing potential for whom a serum pregnancy test (with the results known prior to investigational product administration) is negative. A negative serum pregnancy test will be required for all female subjects with child bearing potential. If a false pregnancy test is suspected, e.g., perimenopausal condition, an obstetrician will be consulted to determine if she is/is capable of becoming pregnant.

Exclusion Criteria:

  • Subject weighs more than 400 pounds (Subjects who weigh more than 400 pounds will not be able to fit inside the imaging machines).
  • 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.)
  • Does the subject have any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance?

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01619865


Locations
United States, Iowa
University of Iowa Health Care
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Sue O'Dorisio
Investigators
Principal Investigator: Sue O'Dorisio, MD University of Iowa Health Care

Responsible Party: Sue O'Dorisio, Professor of Medicine, University of Iowa
ClinicalTrials.gov Identifier: NCT01619865     History of Changes
Other Study ID Numbers: 201110718
114398 ( Other Identifier: FDA )
First Posted: June 14, 2012    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD are entered into the subject's electronic medical record and are shared with referring physicians when obtained.

Keywords provided by Sue O'Dorisio, University of Iowa:
GA-68
Gallium 68
GA-68 PET

Additional relevant MeSH terms:
Neoplasms
Neuroblastoma
Neuroendocrine Tumors
Medulloblastoma
Carcinoid Tumor
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Glioma
Adenocarcinoma
Carcinoma
Octreotide
Somatostatin
Edotreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action