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

Novartis

Status and phase: Completed; Phase 3

Conditions: Neuroendocrine Neoplasms

Treatments: Drug: 68Ge/68Ga Generator; Drug: [68Ga]Ga-DOTA-TATE

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06240741

CAAA501A11301

Details and patient eligibility

About

The purpose of this study was 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 was collected in order to provide the evidence for diagnosis of [68Ga]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.

Full description

A total of 71 participants (48 patients with confirmed/suspected NENs and 23 HVs) were enrolled to ensure that at least 70 participants (47 patients with confirmed/suspected NENs and 23 HVs) were evaluable for the co-primary endpoints. All enrolled participants were administered [68Ga]Ga-DOTA-TATE and PET/CT scan.

The co-primary endpoints of the subject-level sensitivity and the subject-level specificity were assessed by comparing the central reading results of the [68Ga]Ga-DOTA-TATE PET/CT scan to the central reading results of Conventional imaging (CIM).

Enrollment: 71 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Signed informed consent must have been obtained prior to participation in the study
2. Participants must have been adults >= 18 years of age
3. ECOG performance status 0-2
4. For patient with NENs only: Participants were to be confirmed NENs based on histopathology, imaging and other relevant examination, or with suspected NENs which localization could not have been 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 havehad 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 were pregnant.

8. Participants who were lactating.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

[68Ga]Ga-DOTA-TATE

Experimental group

Description:

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)

Treatment:

Drug: [68Ga]Ga-DOTA-TATE

Drug: 68Ge/68Ga Generator