Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
NCT ID: NCT01869725
Last Updated: 2021-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
68 participants
INTERVENTIONAL
2013-04-01
2018-12-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
gallium Ga 68-edotreotide
Given IV
positron emission tomography/computed tomography
Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Interventions
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gallium Ga 68-edotreotide
Given IV
positron emission tomography/computed tomography
Undergo gallium Ga 68-edotreotide PET/CT scan
indium In 111 pentetreotide
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
computed tomography
Undergo indium In 111 pentetreotide contrast-enhanced CT scan
contrast-enhanced magnetic resonance imaging
Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Sue O'Dorisio
OTHER
Responsible Party
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Sue O'Dorisio
Principal Investigator
Principal Investigators
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M. Sue O' Dorisio, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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