Last Update: Aug 02, 2024
A Prospective, Open-label, Multi-center, Single Arm, Phase III Study of [68Ga]Ga-DOTA-TATE in the Diagnosis of Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
ClinicalTrials.gov Identifier:
Novartis Reference Number:CAAA501A11301
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. 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)

Neuroendocrine Neoplasms
Phase3
Recruiting
70
Mar 21, 2024
Dec 31, 2024
All
18 Years - (Adult, Older Adult)

Interventions

Drug

68Ge/68Ga Generator

Radionuclide generator
Drug

[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).

Eligibility Criteria

Key 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.

Key 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.

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