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

NCT01869725 | Completed Phase 2 Results DMC FDA Drug

• 4 other identifiers: 201212736NCI-2013-00936P30CA086862R01CA167632
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Medulloblastoma; Childhood Medulloblastoma; Neuroblastoma; Neuroendocrine Tumor; Somatostatinoma

Keywords

Neuroendocrine Tumor; Ga-DOTATOC PET; Imaging

Outcome Measures

Primary Outcomes (3)

• Comparison of Conventional Imaging and Gallium Ga 68-edotreotide PET Using Concordance in Tumor Detection With Pathology

  Tumor lesions detected on 68Ga-DOTATOC PET/CT compared with tumor lesions detected on Octreoscan SPECT imaging plus high-resolution, contrast-enhanced CT.

  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)

• Compare Sensitivity of 68Ga-DOTATOC PET/CT With Octreoscan

  Compare sensitivity 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

  Up to 6 months

• Compare Specificity of 68Ga-DOTATOC PET/CT With Octreoscan

  Compare specificity 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

  6 months

Study Arms (1)

Diagnostic (gallium Ga 68-edotreotide PET/CT)

EXPERIMENTAL

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.

Drug: gallium Ga 68-edotreotide; Procedure: positron emission tomography/computed tomography; Radiation: indium In 111 pentetreotide; Procedure: computed tomography; Procedure: contrast-enhanced magnetic resonance imaging

Interventions

gallium Ga 68-edotreotide DRUG

Given IV

Also known as: Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC

Diagnostic (gallium Ga 68-edotreotide PET/CT)

positron emission tomography/computed tomography PROCEDURE

Undergo gallium Ga 68-edotreotide PET/CT scan

Diagnostic (gallium Ga 68-edotreotide PET/CT)

indium In 111 pentetreotide RADIATION

Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan

Also known as: Indium-111 Octreotide DTPA, Indium-111-DTPA-D-Phe-1-octreotide, Indium-In 111 Pentetreotide, Indium-In-111-Pentetreotide, Octreoscan

Diagnostic (gallium Ga 68-edotreotide PET/CT)

computed tomography PROCEDURE

Undergo indium In 111 pentetreotide contrast-enhanced CT scan

Also known as: tomography, computed

Diagnostic (gallium Ga 68-edotreotide PET/CT)

contrast-enhanced magnetic resonance imaging PROCEDURE

Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan

Also known as: Contrast-enhanced MRI

Diagnostic (gallium Ga 68-edotreotide PET/CT)

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sue O'Dorisio: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Medulloblastoma; Neuroblastoma; Neuroendocrine Tumors; Somatostatinoma

Interventions

gallium Ga 68 dotatate; Magnetic Resonance Spectroscopy; pentetreotide

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Carcinoma, Neuroendocrine; Adenocarcinoma; Carcinoma; Carcinoma, Islet Cell; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

Although 67/68 were eligible and received the 68Ga-DOTATOC PET scan, four patients did not receive the 111In-Octreotide SPECT scan. Of the 63 subjects who received both scans, 30 subjects did not receive the 111In-Octreotide SPECT scan within either the six months prior to or six months after the 68Ga-DOTATOC PET scan. This left only 34 subjects who could be fully evaluated for comparison of number of lesions found on both scans.

Results Point of Contact

• Title: M. Sue O'Dorisio, MD, PhD
• Organization: University of Iowa

sue-odorisio@uiowa.edu

319-335-7234

Study Officials

• M. Sue O' Dorisio, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: April 1, 2013
• Primary Completion: December 26, 2018
• Study Completion: December 26, 2018
• Last Updated: September 22, 2021
• Results First Posted: September 22, 2021

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)