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

NCT06240741 | Completed Phase 3 Results

• 1 other identifier: CAAA501A11301
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Neuroendocrine Neoplasms

Keywords

[68Ga]Ga-DOTA-TATE; Neuroendocrine Neoplasms (NENs); Positron Emission Tomography (PET); Computerized Tomography (CT); PET/CT; Diagnostic performance; Sensitivity; Specificity

Outcome Measures

Primary Outcomes (4)

• 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 \[TN\]

  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 \[TN\]

  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)

  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).

  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)

  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)

  Day 1

• Subject-level PPV

  Day 1

• Subject-level NPV

  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

  Day 1

Study Arms (1)

[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)

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

Interventions

[68Ga]Ga-DOTA-TATE DRUG

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).

Also known as: AAA501

[68Ga]Ga-DOTA-TATE

68Ge/68Ga Generator DRUG

Radionuclide generator

Also known as: EZR001

[68Ga]Ga-DOTA-TATE

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Eckert & Ziegler Radiopharma GmbH: collaborator

Study Sites (8)

Novartis Investigative Site

Kashiwa, Chiba, 277 8577, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Kanazawa, Ishikawa-ken, 920 8641, Japan

Location

Novartis Investigative Site

Yokohama, Kanagawa-ku, 236-0004, Japan

Location

Novartis Investigative Site

Chuo Ku, Tokyo, 1040045, Japan

Location

Novartis Investigative Site

Fukuoka, 8128582, Japan

Location

Novartis Investigative Site

Fukuoka, 813-0017, Japan

Location

Novartis Investigative Site

Kyoto, 6068507, Japan

Location

Related Links

• Novartis Clinical Trial Results

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@Novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: March 21, 2024
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: February 3, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (8)