Clinical trial NCT01869725: Comparative Study of Sensitivity of Ga-DOTATOC PET vs Octreoscan SPECT + CT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Adult Medulloblastoma
Childhood Medulloblastoma
Neuroblastoma
Neuroendocrine Tumor
Somatostatinoma
Keywords: Neuroendocrine Tumor
Ga-DOTATOC PET
Imaging
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-05
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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 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

Primary outcomes:
measure: Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology
timeFrame: Up to 6 months between the timing of the Octreoscan SPECT/CT plus high-resolution, contrast-enhanced CT and the time of the 68Ga-DOTATOC PET/CT (either imaging type may occur first)
measure: Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan
timeFrame: Up to 6 months
measure: Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: M. Sue O' Dorisio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: