A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan

NCT ID: NCT06240741

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2024-12-27

Brief Summary

The purpose of this study is to evaluate the diagnostic performance of [68Ga]Ga-DOTA-TATE Positron Emission Tomography (PET)/Computerized Tomography (CT) imaging compared with conventional imaging (CIM) as standard of truth in patients with neuroendocrine neoplasms (NENs) and healthy volunteers (HVs). The data from this study will provide the evidence for diagnosis of [68Ga]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.

Detailed Description

All enrolled participants will undergo [68Ga]Ga-DOTA-TATE PET/CT imaging. [68Ga]Ga-DOTA-TATE will be administered intravenously at a dose of 2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi), and PET/CT imaging will be acquired 40 to 90 minutes after the intravenous administration of [68Ga]Ga-DOTA-TATE.

• Duration of screening period is up to 35 days
• Imaging period will be completed within one day followed by safety follow up visit (Day 8) after imaging day (Day 1)

Conditions

Neuroendocrine Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[68Ga]Ga-DOTA-TATE

All eligible participants will receive \[68Ga\]Ga-DOTA-TATE via intravenous injection at a dose of 2 MBq/kg (0.054 mCi/kg) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)

Group Type: EXPERIMENTAL

[68Ga]Ga-DOTA-TATE

Intervention Type: DRUG

Single intravenous injection of \[68Ga\]Ga-DOTA-TATE determined by body weight (2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)) at the imaging day (Day 1).

68Ge/68Ga Generator

Intervention Type: DRUG

Radionuclide generator

Interventions

[68Ga]Ga-DOTA-TATE

Single intravenous injection of \[68Ga\]Ga-DOTA-TATE determined by body weight (2 Mega-Becquerel (MBq) / kilogram (kg) (0.054 Millicurie (mCi)/kilogram (kg)) of body weight up to a maximum total dose of 200 MBq (5.4 mCi)) at the imaging day (Day 1).

Intervention Type: DRUG

68Ge/68Ga Generator

Radionuclide generator

Intervention Type: DRUG

Other Intervention Names

AAA501; EZR001

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent must be obtained prior to participation in the study

2. Participants must be adults >= 18 years of age

3. ECOG performance status 0-2

4. For patient with NENs only: Participants with confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization cannot be confirmed by CIM

5. For HVs only: Male or female participant in good health condition as determined by no clinically significant findings from medical history, physical examination, vital signs, lab test and ECG

6. Women of childbearing potential must have a negative urine or blood pregnancy test.

Exclusion Criteria

1. Inability to complete the needed investigational and conventional imaging due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)

2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation

3. Known allergy, hypersensitivity, or intolerance to [68Ga]Ga-DOTA-TATE and [111In]In-Pentetreotide

4. Therapeutic use of any somatostatin analogue except for the following washout period

• Short-acting analogs of somatostatin can be used up to 24 hours before injection of [68Ga]Ga-DOTA-TATE.
• Long-acting analogs of somatostatin can be used up to 28 days before injection of [68Ga]Ga-DOTA-TATE.

5. Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-DOTA-TATE

6. Use of other investigational drugs within 30 days before screening

7. Participants who are pregnant.

8. Participants who are lactating.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eckert & Ziegler Radiopharma GmbH

UNKNOWN

Sponsor Role: collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Kashiwa, Chiba, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kanazawa, Ishikawa-ken, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Fukuoka, , Japan

Novartis Investigative Site

Kyoto, , Japan

Countries

Japan

Other Identifiers

CAAA501A11301

Identifier Type: -

Identifier Source: org_study_id