Overview
Sponsor-declared trial summary
oncological disease suspicion/ new diagnosis or with a previously treated tumour, with an inconclusive or equivocal findings after the standard clinical/diagnostic flow chart: [18F]F-FDG PET/CT
The study aims to evaluate the accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care path, the diagnostic doubt remains: examination PET / CT with 18F-FDG resulted doubtful for t…
Key facts
- Sponsor
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Jun 2021 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- IRCCS AOUBO Policlinico di S.Orsola (internal funding, donation SOFIE)
External identifiers
- EU CT number
- 2024-518765-96-00
- EudraCT number
- 2020-005549-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Diagnosis, Efficacy
The study aims to evaluate the accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care path, the diagnostic doubt remains: examination PET / CT with 18F-FDG resulted doubtful for the presence of oncological disease or inconclusive in satisfying this diagnostic question.
Secondary objectives 1
- A second objective is to evaluate the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI compared to PET / CT with 18F-FDG (standard tracer currently used in various cancer settings).
Conditions and MedDRA coding
oncological disease suspicion/ new diagnosis or with a previously treated tumour, with an inconclusive or equivocal findings after the standard clinical/diagnostic flow chart: [18F]F-FDG PET/CT
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Age =18 years old • Both sexes • Patients with suspected or newly diagnosed or previously treated neoplasm (prior therapies of at least 3 months), in the presence of inconclusive FDG findings such as: - Suspect primary or secondary (lymph-nodes or distant metastases) lesions with absent/faint FDG uptake (SUVmax
Exclusion criteria 1
- • Pregnant women. The state of pregnancy in women of childbearing potential will be ascertained by measuring serum ß-hCG. • Breastfeeding women • Patients in emergency situations or unable to understand and want • History of allergic reactions or hypersensitivity to the active substance, to any of the excipients, or to any of the components of the radiolabelled radiopharmaceutical • Contraindication to PET / CT examination for patients unable to perform PET due to weight, claustrophobia or the inability to remain still for the duration of the examination • Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives before the study drug • Patients with impaired renal function; • Patients with impaired liver function.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Accuracy of PET / CT with 68Ga-FAPI in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal care pathway, the diagnostic doubt remains: PET / CT examination with 18F-FDG result doubt for the presence of oncological disease or inconclusive in satisfying this diagnostic question.The accuracy of PET / CT with 68Ga-FAPI will be calculated with the following statistical formula: (TRUE POSITIVE+TRUE NE
Secondary endpoints 1
- Evaluation of the accuracy, sensitivity and specificity of PET / CT with 68Ga-FAPI and PET / CT with 18F-FDG in detecting the presence of disease in patients for whom, upon completion of the clinical and instrumental diagnostic procedures required by their normal course care, the diagnostic doubt remains: PET / CT examination with 18F-FDG resulted in doubt due to the presence of oncological disease or inconclusive in satisfying this diagnostic question.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10445641 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 300 MBq megabecquerel(s)
- Max total dose
- 300 MBq megabecquerel(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- AALBORG UNIVERSITY HOSPITAL
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Sponsor organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Address
- Via Pietro Albertoni 15
- City
- Bologna
- Postcode
- 40138
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Contact name
- Stefano Fanti
Public contact point
- Organisation
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Contact name
- Barbara Lotito
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2021-06-03 | 2021-06-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518765-96-00_FP | finale |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_placeholder_FP | N.A. |
| Subject information and informed consent form (for publication) | L1_GP LETTER_FP | final |
| Subject information and informed consent form (for publication) | L1_ICF_data_protection_FP | final |
| Subject information and informed consent form (for publication) | L1_ICF_participation_FP | final |
| Subject information and informed consent form (for publication) | L1_SIS_data_protection_FP | final |
| Subject information and informed consent form (for publication) | L1_SIS_participation_FP | final |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_68Ge_68Ga_FP | N.A. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_VITAMIN C_FP | N.A. |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-518765-96-00_FP | final |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-518765-96-00_FP | final |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-14 | Italy | Acceptable 2024-11-08
|
2024-11-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-05-12 | Italy | Acceptable 2024-11-08
|
2025-05-12 |