Phase 3
N=71
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
Neuroendocrine Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT06240741 ↗Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Feb 2026
Primary outcome: Primary: Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants) — 40; 6 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [68Ga]Ga-DOTA-TATE (Drug); 68Ge/68Ga Generator (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants) |
40; 6 | — |
| PRIMARY Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants) |
23; 2 | — |
| PRIMARY Subject-level Sensitivity |
87.0 | — |
| PRIMARY Subject-level Specificity |
92.0 | — |
| SECONDARY Number of Participants Who Are Positive on Both [68Ga]Ga-DOTA-TATE PET/CT Imagings and CIM (TP Participants) Among Participants Who Are Positive on [68Ga]Ga-DOTA TATE PET/CT Imaging (TP or FP Participants) |
40; 2 | — |
| SECONDARY Number of Participants Who Are Negative on Both [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM (TN Participants) Among Participants Who Are Negative on [68Ga]Ga-DOTA-TATE PET/CT Imaging (TN or FN Participants) |
6; 23 | — |
| SECONDARY Subject-level PPV |
95.2 | — |
| SECONDARY Subject-level NPV |
79.3 | — |
| SECONDARY Participants Who Have Consistent Results (i.e. TP or TN Participants) Among All Participants Assessed by [68Ga]Ga-DOTA-TATE PET/CT Imaging and CIM - Subject-level Accuracy |
88.7 | — |
| SECONDARY Region-level Sensitivity |
77.8; 42.9; 0; 75.0; 84.6 | — |
| SECONDARY Region-level Specificity |
97.1; 89.5; 95.7; 83.6; 94.8 | — |
| SECONDARY Region-level Positive Predictive Values (PPV) |
96.6; 50.0; 0; 57.1; 78.6 | — |
| SECONDARY Region-level Negative Predictive Values (NPV) |
81.0; 86.4; 98.5; 92.0; 96.5 | — |
| SECONDARY Region-level Accuracy |
87.3; 80.3; 94.4; 81.7; 93.0 | — |
| SECONDARY Region-level True Positive |
28; 6; 0; 12; 11 | — |
| SECONDARY Region-level False Negative |
8; 8; 1; 4; 2 | — |
| SECONDARY Region-level False Positive |
1; 6; 3; 9; 3 | — |
| SECONDARY Region-level True Negative |
34; 51; 67; 46; 55 | — |
| SECONDARY Number of Participants Who Underwent a Change in Intended Treatment Plan Attributed to the [68Ga]Ga-DOTA-TATE PET/CT Imaging as Assessed by Pre and Post Imaging Questionnaires |
8; 14; 6; 0; 15; 5 | — |
| SECONDARY Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging |
54; 42; 41; 17; 29; 30 | — |
| SECONDARY Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging |
65.2 | — |
| SECONDARY Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration |
8; 2; 1; 0; 2; 0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
0.420 | — |
| SECONDARY Area Under the Serum Concentration-time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
0.304 | — |
| SECONDARY Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
0.656 | — |
| SECONDARY Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
0.0750 | — |
| SECONDARY Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
1.77 | — |
| SECONDARY Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
26.0 | — |
| SECONDARY Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration] |
66.2 | — |
| SECONDARY Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available |
11; 8; 3; 11; 0; 8 | — |
| SECONDARY Lesion-level Concordance Rate for SSTR Between [68Ga]Ga-DOTA-TATE PET/CT Imaging Local Read and Local Histopathology Result Among Lesions That Local Histopathology Result Are Available - Concordance Rate |
72.7 | — |
Summary
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.
Eligibility Criteria
Key Inclusion Criteria
- Signed informed consent must have been obtained prior to participation in the study
- Participants must have been adults >= 18 years of age
- ECOG performance status 0-2
- 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
- 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
- Women of childbearing potential must havehad a negative urine or blood pregnancy test.
Key Exclusion Criteria
- 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.)
- 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
- Known allergy, hypersensitivity, or intolerance to [68Ga]Ga-DOTA-TATE and [111In]In-Pentetreotide
- 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.
- Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-DOTA-TATE
- Use of other investigational drugs within 30 days before screening
- Participants who were pregnant.
- Participants who were lactating.
Data sourced from ClinicalTrials.gov (NCT06240741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.