Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging
68Ga-NOTA-3P-TATE-RGD for Dual Somatostatin Receptor and Integrin αvβ3 PET/CT Imaging of Lung Cancer and Neuroendocrine Neoplams
1 other identifier
interventional
100
1 country
1
Brief Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 lung-cancer
Started Jun 2016
Longer than P75 for early_phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 7, 2022
March 1, 2022
4.5 years
June 27, 2016
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.
1 year
Study Arms (1)
68Ga-NOTA-3P-TATE-RGD PET/CT
EXPERIMENTALThe patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.
Interventions
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- Neoplasm identified by X-ray, ultrasound or MRI as lung cancer or neuroendocrine tumors
- To provide basic information and sign the written informed consent.
You may not qualify if:
- Consisted of conditions of mental illness;
- Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ) or any hepatic enzyme level 5 times or more than normal upper limit;
- Severe allergy or hypersensitivity to IV radiographic contrast
- Claustrophobia to accept the PET/CT scanning
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospitall, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730, China
Related Publications (1)
Jiang Y, Liu Q, Wang G, Sui H, Wang R, Wang J, Zhu Z. A prospective head-to-head comparison of 68 Ga-NOTA-3P-TATE-RGD and 68 Ga-DOTATATE in patients with gastroenteropancreatic neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4218-4227. doi: 10.1007/s00259-022-05852-3. Epub 2022 Jun 3.
PMID: 35657429DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 29, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 31, 2022
Last Updated
April 7, 2022
Record last verified: 2022-03