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

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.