Neuroendocrine NeoplasmsPhase 3NCT06240741
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
A Phase 3 study testing [68Ga]Ga-DOTA-TATE and 68Ge/68Ga Generator in people with Neuroendocrine Neoplasms, run by Novartis Pharmaceuticals at 8 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuroendocrine Neoplasms
- What is being tested?
- [68Ga]Ga-DOTA-TATE and 68Ge/68Ga Generator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 8 sitesJapan
- Study dates
- 21 Mar 2024to 27 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
Novartis Investigative Site
Fukuoka, 8128582
Novartis Investigative Site
Fukuoka, 813-0017
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920 8641
Novartis Investigative Site
Kashiwa, Chiba, 277 8577
Novartis Investigative Site
Kyoto, 6068507
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648
Novartis Investigative Site
Yokohama, Kanagawa-ku, 236-0004
About this study
Official title: 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
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.
Read the detailed 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).
- Conditions
- Neuroendocrine Neoplasms
- Being tested
- [68Ga]Ga-DOTA-TATE, 68Ge/68Ga Generator
- Keywords
- [68Ga]Ga-DOTA-TATE, Neuroendocrine Neoplasms (NENs), Positron Emission Tomography (PET), Computerized Tomography (CT), PET/CT, Diagnostic performance, Sensitivity, Specificity
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-DOTA-TATEDrug
Also called AAA501
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).
68Ge/68Ga GeneratorDrug
Also called EZR001
Radionuclide generator
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-DOTA-TATE | Experimental | 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) Receives: Drug: [68Ga]Ga-DOTA-TATE; Drug: 68Ge/68Ga Generator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants).
- TP participants were those who showed at least one lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
- FN participants were those who did not show any lesions based on [68Ga]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read.
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Measured: Day 1
Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants)
Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants).
- TN participants were those who did not show any lesions based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
- FP participants were those who showed at least one lesion based on [68Ga]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read.
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Measured: Day 1
Subject-level Sensitivity
Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants).
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Sensitivity = TP / (TP + FN)
Measured: Day 1
Subject-level Specificity
Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants).
True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Specificity = TN / (TN + FP).
Measured: Day 1
Secondary outcomes (27)
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)
Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants).
Measured: Day 1
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)
Subject-level NPV was defined as the proportion of TN participants among [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants).
Measured: Day 1
Subject-level PPV
Subject-level positive predictive values (PPV) is defined as the proportion of TP participants among [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP or FP participants).
PPV (Subject-level positive predictive values) = TP / (TP + FP)
Measured: Day 1
Subject-level NPV
Subject-level NPV was defined as the proportion of TN participants among [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN or FN participants).
NPV (Subject-level negative predictive values) = TN / (TN + FN)
Measured: Day 1
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
Subject-level accuracy is defined as the proportion of TP and TN participants among all patients in the EFF (i.e. TP+TN+FP+FN participants).
Accuracy = (TP + TN) / (TP + TN + FP + FN).
Measured: Day 1
Region-level Sensitivity
Region-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive regions (TP regions) among CIM positive regions (i.e. TP or FN regions).
Sensitivity = TP / (TP + FN)
Measured: Day 1
Region-level Specificity
Region-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative regions (TN regions) among CIM negative regions (i.e. TN or FP regions).
Specificity = TN / (TN + FP)
Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participant is categorized as positive in subject-level. As all participants had at least one CIM-negative region and were included in the table, the number of participants analyzed is 71.
Measured: Day 1
Region-level Positive Predictive Values (PPV)
Region-level PPV is defined as the proportion of regions which are positive on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM (TP regions) among [68Ga]Ga-DOTA-TATE PET/CT imaging positive regions (i.e. TP or FP regions).
Region-level positive predictive values (PPV) = TP / (TP +FP)
Measured: Day 1
Region-level Negative Predictive Values (NPV)
Region-level NPV is defined as the proportion of regions which are negative on both [68Ga]Ga- DOTA-TATE PET/CT imaging and CIM (TN regions) among [68Ga]Ga-DOTA-TATE PET/CT imaging negative regions (i.e. TN or FN regions).
Region-level negative predictive values (NPV) = TN / (TN + FN)
Note: Even when a participant is categorized as positive in subject-level, he/she can still have negative results in region-level. e.g. When only Liver is positive and other regions are negative, the participants is categorized as positive in subject-level. As all participants had at least one negative region by Ga-DOTA-TATE PET/CT and were included in the table, the number of participants analyzed = 71.
Measured: Day 1
Region-level Accuracy
Region-level accuracy is defined as the proportion of regions which are CIM and [68Ga]Ga-DOTA-TATE PET/CT imaging positive (TP regions) or negative (TN regions) among regions detected by CIM and [68Ga]Ga-DOTA-TATE PET/CT imaging (i.e. TP+TN+FP+FN regions).
Accuracy = (TP + TN) / (TP + TN + FP + FN).
Measured: Day 1
Region-level True Positive
TP regions were the regions which showed at least one lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read
Measured: Day 1
Region-level False Negative
FN regions were the regions which did not show any lesions based on [68Ga]Ga-DOTA-TATE PET/CT imaging but show at least one lesion based on CIM by central read.
Measured: Day 1
Region-level False Positive
FP regions were the regions which showed at least one lesion based on [68Ga]Ga-DOTA-TATE PET/CT imaging but do not showed any lesion based on CIM by central read.
Measured: Day 1
Region-level True Negative
TN regions were the regions which did not show any lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read.
Measured: Day 1
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
Numbers of participants for each intended treatment plan collected from physician at pre and post [68Ga]Ga-DOTA-TATE PET/CT imaging will be summarized.
Measured: Before and after imaging on Day 1
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
The assessment of [68Ga]Ga-DOTA-TATE PET/CT images set was compared among the 3 independent readers.
Measured: Day 1
Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Inter-reader variability for [68Ga]Ga-DOTA-TATE PET/CT imaging is defined as agreement rate among reader determinations.
As assessed by Fleiss' Kappa statistics. Inter-reader variability (%) and its normality 95% CI is presented.
Measured: Day 1
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
An adverse event (AE) is any untoward medical occurrence (e.g., any occurrence of unfavorable and unintended sign(s), symptom(s) or medical condition, including abnormal laboratory findings, or worsening of any pre-existing sign(s), symptom(s) or medical condition) in a participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of any treatment used in this study. This includes events reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally authorized representative).
Measured: For treated pts: AEs are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days. For HV pts: AEs are reported from the study start plus 8 days, up to a maximum timeframe of 9 days.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUC(0-inf) will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
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]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. AUClast will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Cmax will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Tmax will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. CL will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Vz will be listed and summarized using descriptive statistics.
Measured: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
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
The lesion-level concordance rate for SSTR between [68Ga]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of [68Ga]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology.
Measured: Day 1 to Day 30
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
The lesion-level concordance rate for SSTR between [68Ga]Ga-DOTA-TATE PET/CT imaging local read and local histopathology result among legions which is available, will be calculated. The rate is defined as the proportion of lesions which are positive or negative on both local read of [68Ga]Ga-DOTA-TATE PET/CT imaging and local histopathology among lesions detected by local histopathology.
Measured: Day 1 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start21 Mar 2024
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuroendocrine NeoplasmsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eckert & Ziegler Radiopharma GmbH
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240741
- Sponsor's protocol ID
- CAAA501A11301
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2024
- Last updated
- 3 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 ID
- NCT06240741
- Acronym / sponsor ID
- CAAA501A11301
- Conditions
- Neuroendocrine Neoplasms
- Keywords
- [68Ga]Ga-DOTA-TATE, Neuroendocrine Neoplasms (NENs), Positron Emission Tomography (PET), Computerized Tomography (CT), PET/CT, Diagnostic performance, Sensitivity, Specificity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Eckert & Ziegler Radiopharma GmbH
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 5 Feb 2024 (actual)
- Results
- Posted 3 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-DOTA-TATE | Experimental | Drug: [68Ga]Ga-DOTA-TATE, Drug: 68Ge/68Ga GeneratorAll 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
- Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection of [68Ga]Ga-DOTA-TATE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-DOTA-TATEAlso: AAA501Single 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). | Drug | [68Ga]Ga-DOTA-TATE |
| 68Ge/68Ga GeneratorAlso: EZR001Radionuclide generator | Drug | [68Ga]Ga-DOTA-TATE |
Primary outcome
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants)
Time frame: Day 1
Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). * TP participants were those who showed at least one lesion based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FN participants were those who did not show any lesions based on [68Ga]Ga-DOTA-TATE PET/CT imaging but showed at least one lesion based on CIM by central read. True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Number of [68Ga]Ga-DOTA-TATE Negative Participants (TN Participants) Among CIM Negative Participants (TN or FP Participants)
Time frame: Day 1
Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). * TN participants were those who did not show any lesions based on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM by central read. * FP participants were those who showed at least one lesion based on [68Ga]Ga-DOTA-TATE PET/CT imaging but did not show any lesions based on CIM by central read. True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN]
Subject-level Sensitivity
Time frame: Day 1
Subject-level sensitivity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging positive participants (i.e. TP participants) among CIM positive participants (i.e. TP or FN participants). True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] Sensitivity = TP / (TP + FN)
Subject-level Specificity
Time frame: Day 1
Subject-level specificity is defined as the proportion of [68Ga]Ga-DOTA-TATE PET/CT imaging negative participants (i.e. TN participants) among CIM negative participants (i.e. TN or FP participants). True Positive [TP] False Positive [FP] False Negative [FN] True Negative [TN] Specificity = TN / (TN + FP).
27 secondary outcomes
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)
Time frame: Day 1
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)
Time frame: Day 1
Subject-level PPV
Time frame: Day 1
Subject-level NPV
Time frame: Day 1
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
Time frame: Day 1
Region-level Sensitivity
Time frame: Day 1
Region-level Specificity
Time frame: Day 1
Region-level Positive Predictive Values (PPV)
Time frame: Day 1
Region-level Negative Predictive Values (NPV)
Time frame: Day 1
Region-level Accuracy
Time frame: Day 1
Region-level True Positive
Time frame: Day 1
Region-level False Negative
Time frame: Day 1
Region-level False Positive
Time frame: Day 1
Region-level True Negative
Time frame: Day 1
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
Time frame: Before and after imaging on Day 1
Inter-reader Agreement on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Time frame: Day 1
Inter-reader Variability (%) on [68Ga]Ga-DOTA-TATE PET/CT Imaging
Time frame: Day 1
Incidence of Treatment Emergent Adverse Event (TEAE) Within 8 Days After [68Ga]Ga-DOTATATE Administration
Time frame: For treated pts: AEs are reported from the single dose of study treatment plus 8 days post treatment, up to a maximum timeframe of 9 days. For HV pts: AEs are reported from the study start plus 8 days, up to a maximum timeframe of 9 days.
Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUCinf) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
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]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Observed Maximum Plasma Concentration (Cmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Time of Maximum Observed Drug Concentration Occurrence (Tmax) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Terminal Elimination Half-life (T1/2) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Total Systemic Clearance for Intravenous Administration (CL) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) of [68Ga]Ga-DOTA-TATE [Mass-based Concentration]
Time frame: Day 1 (5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
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
Time frame: Day 1 to Day 30
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
Time frame: Day 1 to Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Novartis Clinical Trial ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [68Ga]Ga-DOTA-TATE and 68Ge/68Ga Generator in people with Neuroendocrine Neoplasms, run by Novartis Pharmaceuticals at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of [68Ga]Ga-DOTA-TATE Positive Participants (TP Participants) Among CIM Positive Participants (TP or FN Participants) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.