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Ga-DOTATOC Versus Octreoscan + CT

This study has suspended participant recruitment.
(Interim analysis. Decision has not yet been made regarding additional enrollment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01869725
First Posted: June 5, 2013
Last Update Posted: August 25, 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. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sue O'Dorisio, University of Iowa
  Purpose
This clinical trial studies gallium Ga 68-edotreotide positron emission tomography (PET)/computed tomography (CT) compared with indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosing patients with neuroendocrine tumors and other somatostatin receptor positive tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/CT, may help find and diagnose somatostatin receptor positive neuroendocrine tumors. It is not yet known whether Ga 68-edotreotide PET/CT is as effective as indium In 111 pentetreotide plus contrast-enhanced CT (or MRI) in diagnosis and staging of patients with neuroendocrine tumors.

Condition Intervention
Adult Medulloblastoma Childhood Medulloblastoma Neuroblastoma Neuroendocrine Tumor Somatostatinoma Radiation: gallium Ga 68-edotreotide Procedure: positron emission tomography/computed tomography Radiation: indium In 111 pentetreotide Procedure: computed tomography Procedure: contrast-enhanced magnetic resonance imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparator Study of 68Ga-DOTATOC PET/CT With Octreoscan + High-resolution, Contrast-enhanced CT for Diagnosis and Staging in Neuroendocrine Tumors and Other Somatostatin Receptor Positive Tumors

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Equivalence of conventional imaging and gallium Ga 68-edotreotide PET using percentage of concordance in tumor detection [ Time Frame: Up to 6 months ]
    Binomial exact tests will be used.

  • Proportion of discordance in tumor detection [ Time Frame: Up to 6 months ]
    Binomial exact tests will be used.


Estimated Enrollment: 112
Study Start Date: April 2013
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (gallium Ga 68-edotreotide PET/CT)
Patients receive gallium Ga 68-edotreotide IV and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.
Radiation: gallium Ga 68-edotreotide
Given IV
Other Names:
  • Ga-68 DOTA0-Tyr3-octreotide
  • Ga-68 DOTATOC
Procedure: positron emission tomography/computed tomography
Undergo gallium Ga 68-edotreotide PET/CT scan
Radiation: indium In 111 pentetreotide
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Other Names:
  • Indium-111 Octreotide DTPA
  • Indium-111-DTPA-D-Phe-1-octreotide
  • Indium-In 111 Pentetreotide
  • Indium-In-111-Pentetreotide
  • Octreoscan
Procedure: computed tomography
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
Other Name: tomography, computed
Procedure: contrast-enhanced magnetic resonance imaging
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Other Name: Contrast-enhanced MRI

Detailed Description:

PRIMARY OBJECTIVES:

I. To compare efficacy of [68Ga]-DOTA-tyr3-Octreotide (68Ga-DOTATOC) (gallium Ga 68-edotreotide) PET/CT with Octreoscan (indium In 111 pentetreotide) + high-resolution, contrast-enhanced CT for diagnosis and staging in patients with somatostatin receptor expressing tumors.

OUTLINE:

Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/CT scan. Within 120 days, patients undergo standard indium In 111 pentetreotide contrast-enhanced CT or MRI scan. Patients may also undergo a second gallium Ga 68-edotreotide PET/CT scan within 3-6 months if the lesions of the first scan cannot be confirmed.

  Eligibility

Information from the National Library of Medicine

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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
  • Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or other somatostatin receptor positive tumor
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
  • Karnofsky performance status or Lansky Play Scale status of >= 50 (or Eastern Cooperative Oncology Group [ECOG]/World Health Organization [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
  • No therapy other than Sandostatin since last Octreoscan + diagnostic CT
  • Fresh frozen (recommended) or paraffin fixed (required) specimen of primary or metastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
  • Medical condition uncontrolled by treatment making completion of study unlikely
  • Weight 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.)
  • 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
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): NCT01869725


Locations
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
National Cancer Institute (NCI)
Investigators
Principal Investigator: M. Sue O' Dorisio University of Iowa
  More Information

Responsible Party: Sue O'Dorisio, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT01869725     History of Changes
Other Study ID Numbers: 201212736
NCI-2013-00936 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA086862 ( U.S. NIH Grant/Contract )
R01CA167632 ( U.S. NIH Grant/Contract )
First Submitted: May 31, 2013
First Posted: June 5, 2013
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Sue O'Dorisio, University of Iowa:
Neuroendocrine Tumor
Ga-DOTATOC PET
Imaging

Additional relevant MeSH terms:
Neuroblastoma
Neuroendocrine Tumors
Carcinoid Tumor
Medulloblastoma
Somatostatinoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Glioma
Carcinoma, Neuroendocrine
Carcinoma, Islet Cell
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Octreotide
Edotreotide
Indium-111-octreotide
Somatostatin