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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

2 Years
Open (Enrolling)
Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma, Neuroendocrine Tumor, Somatostatinoma

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Trial Information

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


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.


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.

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,

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Equivalence of conventional imaging and gallium Ga 68-edotreotide PET using percentage of concordance in tumor detection

Outcome Description:

Binomial exact tests will be used.

Outcome Time Frame:

Up to 6 months

Safety Issue:


Principal Investigator

M. Sue O' Dorisio

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

April 2013

Completion Date:

Related Keywords:

  • Adult Medulloblastoma
  • Childhood Medulloblastoma
  • Neuroblastoma
  • Neuroendocrine Tumor
  • Somatostatinoma
  • Neuroendocrine Tumor
  • Imaging
  • Medulloblastoma
  • Neuroblastoma
  • Somatostatinoma
  • Neuroendocrine Tumors



University of Iowa Hospitals and ClinicsIowa City, Iowa  52242