A single arm Japanese phase III study of [68Ga]Ga-DOTA-TATE in patients with NENs and healthy volunteers

JRCT ID: jRCT2071230114

Registered date:08/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neuroendocrine neoplasms (NENs)
• Date of first enrollment: 20/03/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): [68Ga]Ga-DOTA-TATE will be administered intravenously at the imaging day.

Outcome(s)

Primary Outcome

- Proportion of [68Ga]Ga-DOTA-TATE positive participants (TP participants) among CIM positive participants (TP or FN participants).
- Proportion of [68Ga]Ga-DOTA-TATE negative participants (TN participants) among CIM negative participants (TN or FP participants).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 lacting.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT06240741