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Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

This study is currently recruiting participants.
Verified August 2017 by Sue O'Dorisio, University of Iowa
Sponsor:
ClinicalTrials.gov Identifier:
NCT02441062
First Posted: May 12, 2015
Last Update Posted: August 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of Iowa Foundation
Information provided by (Responsible Party):
Sue O'Dorisio, University of Iowa
  Purpose

Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors.

The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.


Condition Intervention Phase
Neuroendocrine Tumors Carcinoid Tumors Neuroblastoma Medulloblastoma Drug: 68Ga-DOTATOC PET/CT Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Sue O'Dorisio, University of Iowa:

Primary Outcome Measures:
  • Evaluate impact of 68Gallium-DOTATOC PET/CT imaging on tumor management [ Time Frame: 36 months ]
    Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET (Table 2).


Estimated Enrollment: 200
Study Start Date: September 2015
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
Drug: 68Ga-DOTATOC PET/CT
Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors

Detailed Description:
This is a prospective, Phase II, single center, open-label study in a total of 200 participants with histologically proven neuroendocrine tumor or other somatostatin receptor positive tumors. Eligible participants will undergo baseline assessments at enrollment. They will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Participants may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Age ≥ 6 months
  3. Histologically diagnosed neuroendocrine tumor or other tumor with probable somatostatin receptors subtype 2
  4. Karnofsky performance status or Lansky Play Scale status of ≥ 60 (or ECOG/WHO equivalent)
  5. Subject is male; or is a female who is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (> 1 years without menses), ≥60 years old,or of childbearing potential for whom a pregnancy test (with the results known prior to investigational product administration) is negative. A negative 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 not capable of becoming pregnant. Female must also be non-lactating.

Exclusion Criteria:

  1. Subject weighs more than 450 pounds. (Subjects who weigh more than 450 pounds will not be able to fit inside the imaging machines) or otherwise cannot be safely fit into the imaging system.
  2. Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
  3. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  4. Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
  5. Peptide receptor radionuclide therapy (PRRT) within 4 weeks of Ga-68 DOTATOC PET/CT scan.
  6. Treatment with Sandostatin LAR within 4 weeks, SQ Octreotide within 12 hours, or Lanreotide injection within 8 weeks of Ga-68 DOTATOC PET/CT (+/-5%).
  Contacts and Locations
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): NCT02441062


Contacts
Contact: Mary S O'Dorisio, MD, PhD 319-356-7873 sue-odorisio@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Mary S O'Dorisio, MD, PhD         
Sponsors and Collaborators
Sue O'Dorisio
University of Iowa Foundation
Investigators
Principal Investigator: Mary S O'Dorisio, MD, PhD University of Iowa
  More Information

Responsible Party: Sue O'Dorisio, Professor, Pediatrics Hematology/Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT02441062     History of Changes
Other Study ID Numbers: 201503708
First Submitted: May 4, 2015
First Posted: May 12, 2015
Last Update Posted: August 24, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Neoplasms
Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Medulloblastoma
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
Adenocarcinoma
Carcinoma
Glioma
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents