Clinical trial NCT06240741: A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neuroendocrine Neoplasms
Keywords: [68Ga]Ga-DOTA-TATE
Neuroendocrine Neoplasms (NENs)
Positron Emission Tomography (PET)
Computerized Tomography (CT)
PET/CT
Diagnostic performance
Sensitivity
Specificity
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Eckert & Ziegler Radiopharma GmbH
First posted: 2024-02-05
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is 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 will provide the evidence for diagnosis of \[68Ga\]Ga-DOTA-TATE PET/CT imaging in patient with NENs in Japan.

Detailed description: All enrolled participants will undergo \[68Ga\]Ga-DOTA-TATE PET/CT imaging. \[68Ga\]Ga-DOTA-TATE will be administered intravenously at a dose of 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), and PET/CT imaging will be acquired 40 to 90 minutes after the intravenous administration of \[68Ga\]Ga-DOTA-TATE.

* Duration of screening period is up to 35 days
* Imaging period will be completed within one day followed by safety follow up visit (Day 8) after imaging day (Day 1)

Eligibility criteria: Key Inclusion 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.

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 are pregnant.
8. Participants who are lactating.

Primary outcomes:
measure: Proportion of [68Ga]Ga-DOTA-TATE positive participants (TP participants) among CIM positive participants (TP or FN participants)
timeFrame: Day 1
measure: Proportion of [68Ga]Ga-DOTA-TATE negative participants (TN participants) among CIM negative participants (TN or FP participants)
timeFrame: Day 1
Secondary outcomes:
measure: Proportion 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)
timeFrame: Day 1
measure: Proportion 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)
timeFrame: Day 1
measure: Proportion of 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
timeFrame: Day 1
measure: Proportion of [68Ga]Ga-DOTA-TATE positive regions (TP regions) among CIM positive regions (TP or FN regions)
timeFrame: Day 1
measure: Proportion of [68Ga]Ga-DOTA-TATE negative regions (TN regions) among CIM negative regions (TN or FP regions)
timeFrame: Day 1
measure: Proportion of regions which are positive on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM (TP regions) among regions which are positive on [68Ga]Ga-DOTA-TATE PET/CT imaging (TP or FP regions)
timeFrame: Day 1
measure: Proportion of regions who are negative on both [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM (TN regions) among regions which are negative on [68Ga]Ga-DOTA-TATE PET/CT imaging (TN or FN regions)
timeFrame: Day 1
measure: Proportion of regions which have consistent results (i.e. TP or TN regions) among all regions assessed by [68Ga]Ga-DOTA-TATE PET/CT imaging and CIM
timeFrame: Day 1
measure: Number of lesions detected by [68Ga]Ga-DOTA-TATE PET/CT imaging and each CIM at region-level
timeFrame: Day 1
measure: Percentage of patients 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
timeFrame: Day 1
measure: Inter-reader agreement on [68Ga]Ga-DOTA-TATE PET/CT imaging
timeFrame: Day 1
measure: 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
timeFrame: Day 1 to Day 30
measure: Incidence of Treatment emergent adverse event (TEAE) within 8 days after [68Ga]Ga-DOTATATE administration
timeFrame: Day1 to Day 8
measure: Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUCinf) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Area under the serum concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Observed maximum plasma concentration (Cmax) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Time of maximum observed drug concentration occurrence (Tmax) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Terminal elimination half-life (T1/2) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Total systemic clearance for intravenous administration (CL) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
measure: Volume of distribution during the terminal phase following intravenous elimination (Vz) of [68Ga]Ga-DOTA-TATE
timeFrame: Day 1 (Pre-dose, 5 min, 15 min, 30 min, 45 min, 60 min, 120 min, 180 min)
Other outcomes:
Locations:
city: Kashiwa
country: Japan
facility: Novartis Investigative Site
state: Chiba
city: Fukuoka city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Sapporo city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kanazawa
country: Japan
facility: Novartis Investigative Site
state: Ishikawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
city: Kyoto
country: Japan
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: