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Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

Primary Purpose

Neuroendocrine Carcinoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

68Ga-DOTATATE

About this trial

This is an interventional diagnostic trial for Neuroendocrine Carcinoma focused on measuring Neuroendocrine Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence.
At least 18 years of age.
Patient or patient's legally acceptable representative cognitively provides written informed consent.
Able to provide informed consent.
Females of childbearing potential must have a negative pregnancy test at screening/baseline.

Exclusion Criteria:

Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments.
Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
Inability to lie still for the entire imaging time.
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Recognized concurrent active infection.
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 California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostics with PET

Arm Description

68Ga-DOTATATE PET scans will be performed on subjects

Outcomes

Primary Outcome Measures

Measure the number of adverse events in patients receiving Ga68-DOTATATE PET

We'll assess the safety and tolerability of Ga68-DOTATATE PET

Secondary Outcome Measures

Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques

We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).

Full Information

NCT ID

NCT01873248

First Posted

June 3, 2013

Last Updated

May 12, 2021

Sponsor

Jonsson Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01873248

Brief Title

Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

Official Title

Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

August 26, 2013 (Actual)

Primary Completion Date

June 16, 2017 (Actual)

Study Completion Date

June 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jonsson Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, Phase 1-2, single center study in a total of 100 subjects with Neuroendocrine Tumors (NETs). Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study, to investigate its suitability as a PET imaging agent for NETs.

Detailed Description

In this study, we propose to use a well-established PET isotope, 68-Gallium (68Ga), bound to a somatostatin analogue, DOTA-octreotate, or DOTATATE, which has high affinity for the somatostatin receptor type 2 (SSTR2). Most gastro-entero-pancreatic (GEP) NETs express SSTR2 on their cell surfaces; when the radiolabeled SSTR2 analogue binds to these receptors, the radioactive molecule is internalized and transported to the tumor cell nucleus, thus concentrating the radioactivity and improving the signal-to-noise ratio on the PET scan, particularly as the background rapidly clears. This internalization, combined with the improved physical principles of PET imaging, shorter half-life of the 68Ga (68 minutes vs. about three days for 111In), improved radiation dosimetry, faster scanning, and lower cost results in a greatly improved scan for diagnosis, staging and restaging of NET disease compared to conventional 111In-octreotide imaging. Additionally, 68Ga-DOTATATE PET/CT scanning can be performed in 1.5 hours from injection of the radiopharmaceutical to completion of the scan, vs. 2-3 days for 111In-octreotide imaging.

6. Conditions and Keywords

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

Neuroendocrine Carcinoma

Keywords

Neuroendocrine Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

238 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diagnostics with PET

Arm Type

Experimental

Arm Description

68Ga-DOTATATE PET scans will be performed on subjects

Intervention Type

Drug

Intervention Name(s)

68Ga-DOTATATE

Other Intervention Name(s)

68Ga-DOTATATE PET/CT scan

Intervention Description

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.

Primary Outcome Measure Information:

Title

Measure the number of adverse events in patients receiving Ga68-DOTATATE PET

Description

We'll assess the safety and tolerability of Ga68-DOTATATE PET

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques

Description

We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT).

Time Frame

3 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Known diagnosis of NET, suspected SSTR positive tumors or suspected NET recurrence. At least 18 years of age. Patient or patient's legally acceptable representative cognitively provides written informed consent. Able to provide informed consent. Females of childbearing potential must have a negative pregnancy test at screening/baseline. Exclusion Criteria: Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments. Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result. Inability to lie still for the entire imaging time. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Recognized concurrent active infection. 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

Johannes Czernin, MD

Organizational Affiliation

University of California, Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18780869

Citation

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Links:

URL

http://www.pet.ucla.edu

Description

Ahmanson Imaging Division

URL

http://www.pharmacology.ucla.edu

Description

Department of Molecular and Medical Pharmacology UCLA

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Investigation of 68Ga-DOTATATE, as a PET Imaging Agent in Neuroendocrine Tumor Patients

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