Lung adenocarcinoma MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: 68Ga-PSMA-11
Product Code: [68Ga-PSMA-11]
Pharmaceutical Form: Solution for injection
Current Sponsor code: N.A
Concentration unit: MBq/kg megabecquerel(s)/kilogram
Concentration type: e
Sponsors
AZIENDA OSPEDALIERA SANT'ANDREA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - men or women aged 18 or older; - histologically proven lung adenocarcinoma; - disease staging by PET/CT with 18F-FDG; - patients candidates for surgical removal of the neoplasm; - signature of informed consent; patients must sign an informed consent stating that they understand the experimental nature of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - pregnancy or breastfeeding; - positive pregnancy test for women of childbearing potential - history of allergic reaction to the active substance or to any of the components of the radiopharmaceutical - presence of heart or respiratory diseases that represent a contra-indication to the surgical intervention; - inoperable patients for allergies or hypersensitivity to anesthetics; - participation in a clinical trial in which an investigational drug was administered within 30 days of 5 half-lives prior to the study drug - inability to maintain a supine position for the entire duration of the study (for example due to cough, severe arthritis, etc.) or to complete the study for other reasons (for example due to claustrophobia not responsive to oral anxiolytics, radio- phobia etc.). - patients with grade 3 renal of hepatic impairment according to US National Cancer Institute's "Common Terminology Criteria for Adverse Events V5” (CTCAE).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the ability of PET/CT with 68Ga-PSMA-11 to highlight PSMA expression in pulmonary lesions of lung adenocarcinoma patients in vivo;Secondary Objective: Correlation between radiopharmaceutical uptake gradient in lung lesions with PET/CT imaging with 68Ga-PSMA-11 and results of immunohistochemical analysis performed on the operating piece Correlation between radiopharmaceutical uptake gradient in lung lesions with PET/CT imaging with 68Ga-PSMA-11 and degree of neoplasm differentiation Correlation between radiopharmaceutical uptake gradients in lung lesions respectively on PET/CT imaging with 68Ga-PSMA-11 and 18F-DFG;Primary end point(s): Assessment of the "detection rate" (ratio between the number of patients with PET imaging positive lesions and the total number of patients) of 68Ga-PSMA-11 in lung lesions of patients with lung adenocarcinoma;Timepoint(s) of evaluation of this end point: Days 1-7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Correlation between mean and maximal standardized uptake values (SUVmean, SUVmax) measured on lung lesions on PET-CT imaging with 68Ga-PSMA-11 and percentage of positivity for anti-PSMA antibodies detected at the immunohistochemical analysis performed on the operating piece; Correlation between mean and maximal standardized uptake values (SUVmean, SUVmax) measured on lung lesions on PET-CT imaging with 68Ga-PSMA-11 and degree of neoplasm differentiation; Correlation between radiopharmaceutical uptake gradients in lung lesions respectively on PET/CT imaging with 68Ga-PSMA-11 and 18F-DFG;Timepoint(s) of evaluation of this end point: Days 18-27; Days 18-27; Days 1-7 | — |
Countries
Italy
Contacts
Public ContactUOC Medicina Nucleare
Azienda Ospedaliera Sant'Andrea
Outcome results
None listed