Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT

Last updated: August 26, 2021
Sponsor: Sue O'Dorisio
Overall Status: Completed

Phase

2

Condition

Brain Cancer

Neuroendocrine Carcinoma

Gliomas

Treatment

N/A

Clinical Study ID

NCT01869725
201212736
R01CA167632
NCI-2013-00936
P30CA086862
  • Ages > 2
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed informed consent
  • Biopsy proven neuroendocrine tumor, neuroblastoma, medulloblastoma, or othersomatostatin receptor positive tumor
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and offimmediate release (subcutaneous) for 12 hrs prior to 68Ga-DOTATOC PET-CT
  • Karnofsky performance status or Lansky Play Scale status of >= 50 (or EasternCooperative Oncology Group [ECOG]/World Health Organization [WHO] equivalent)
  • Subject is male; or is a female who is either pre-menarchal, surgically sterile (hashad a documented bilateral oophorectomy and/or documented hysterectomy),postmenopausal (> 1 years without menses), non-lactating, or of childbearing potentialfor whom a serum pregnancy test (with the results known prior to investigationalproduct administration) is negative; a negative serum pregnancy test will be requiredfor all female subjects with child bearing potential; if a false pregnancy test issuspected, e.g., perimenopausal condition, an obstetrician will be consulted todetermine 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 ormetastases available for ribonucleic acid (RNA) and immunohistochemistry (IHC)

Exclusion

Exclusion Criteria:

  • Pregnancy or breast feeding
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since lastOctreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneousSandostatin 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 ableto 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 imagingexaminations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Any additional medical condition, serious intercurrent illness, or other extenuatingcircumstance that, in the opinion of the investigator, may significantly interferewith study compliance

Study Design

Total Participants: 68
Study Start date:
April 01, 2013
Estimated Completion Date:
December 26, 2018

Study 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.

Connect with a study center

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Site Not Available

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