To hear about similar clinical trials, please enter your email below
Trial Title:
A Prospective, Open-label Study of [68Ga]Ga-DOTA-TATE in Patients With Neuroendocrine Neoplasms (NENs) and Healthy Volunteers in Japan
NCT ID:
NCT06240741
Condition:
Neuroendocrine Neoplasms
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Conditions: Keywords:
[68Ga]Ga-DOTA-TATE
Neuroendocrine Neoplasms (NENs)
Positron Emission Tomography (PET)
Computerized Tomography (CT)
PET/CT
Diagnostic performance
Sensitivity
Specificity
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]Ga-DOTA-TATE
Description:
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).
Arm group label:
[68Ga]Ga-DOTA-TATE
Other name:
AAA501
Intervention type:
Drug
Intervention name:
68Ge/68Ga Generator
Description:
Radionuclide generator
Arm group label:
[68Ga]Ga-DOTA-TATE
Other name:
EZR001
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)
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kashiwa
Zip:
277 8577
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukuoka city
Zip:
812-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Sapporo city
Zip:
060 8648
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kanazawa
Zip:
920 8641
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Yokohama-city
Zip:
236-0004
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Chuo ku
Zip:
104 0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukuoka-city
Zip:
813-0017
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Fukuoka
Zip:
811-0213
Country:
Japan
Status:
Recruiting
Facility:
Name:
Novartis Investigative Site
Address:
City:
Kyoto
Zip:
606 8507
Country:
Japan
Status:
Recruiting
Start date:
March 21, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Novartis Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
Eckert & Ziegler Radiopharma GmbH
Agency class:
Other
Source:
Novartis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06240741
