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Gallium Ga 68-Edotreotide PET/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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Iowa
Sponsor:
Collaborator:
Information provided by (Responsible Party):
O'Dorisio, M S, University of Iowa
ClinicalTrials.gov Identifier:
NCT01869725
First received: May 31, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
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 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 ] [ Designated as safety issue: No ]
    Binomial exact tests will be used.

  • Proportion of discordance in tumor detection [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Binomial exact tests will be used.


Estimated Enrollment: 112
Study Start Date: April 2013
Estimated Primary Completion Date: January 2015 (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

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
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: NCT01869725

Contacts
Contact: Suzanne Kieffer 319-530-8051 suzanne-kieffer@uiowa.edu

Locations
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: M. Sue S. O' Dorisio    319-356-3595    sue-odorisio@uiowa.edu   
Principal Investigator: M. Sue S. O' Dorisio         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: M. Sue O' Dorisio University of Iowa
  More Information

No publications provided

Responsible Party: O'Dorisio, M S, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT01869725     History of Changes
Other Study ID Numbers: 201212736, NCI-2013-00936, P30CA086862, R01CA167632
Study First Received: May 31, 2013
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Neuroendocrine Tumor
Ga-DOTATOC PET
Imaging

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

ClinicalTrials.gov processed this record on November 25, 2014