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

Primary Purpose

Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

gallium Ga 68-edotreotide

positron emission tomography/computed tomography

indium In 111 pentetreotide

computed tomography

contrast-enhanced magnetic resonance imaging

About this trial

This is an interventional diagnostic trial for Adult Medulloblastoma focused on measuring Neuroendocrine Tumor, Ga-DOTATOC PET, Imaging

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (gallium Ga 68-edotreotide PET/CT)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01869725

First Posted

May 31, 2013

Last Updated

August 26, 2021

Sponsor

Sue O'Dorisio

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01869725

Brief Title

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

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

April 1, 2013 (Actual)

Primary Completion Date

December 26, 2018 (Actual)

Study Completion Date

December 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sue O'Dorisio

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Medulloblastoma, Childhood Medulloblastoma, Neuroblastoma, Neuroendocrine Tumor, Somatostatinoma

Keywords

Neuroendocrine Tumor, Ga-DOTATOC PET, Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (gallium Ga 68-edotreotide PET/CT)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

gallium Ga 68-edotreotide

Other Intervention Name(s)

Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

positron emission tomography/computed tomography

Intervention Description

Undergo gallium Ga 68-edotreotide PET/CT scan

Intervention Type

Radiation

Intervention Name(s)

indium In 111 pentetreotide

Other Intervention Name(s)

Indium-111 Octreotide DTPA, Indium-111-DTPA-D-Phe-1-octreotide, Indium-In 111 Pentetreotide, Indium-In-111-Pentetreotide, Octreoscan

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

computed tomography

Other Intervention Name(s)

tomography, computed

Intervention Description

Undergo indium In 111 pentetreotide contrast-enhanced CT scan

Intervention Type

Procedure

Intervention Name(s)

contrast-enhanced magnetic resonance imaging

Other Intervention Name(s)

Contrast-enhanced MRI

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

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)

Title

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

Description

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

Time Frame

Up to 6 months

Title

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

Description

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

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

M. Sue O' Dorisio, MD, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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