[18F]F-FAPI PET-CT to Identify Carcinoma of Unknown Primary origin

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

12 Jul 2024 → ongoing

Decision date (initial)

2024-03-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To determine the proportion of CUP patients in whom the primary tumor can be identified by [18F]F-FAPI PET/CT.

Secondary objectives 1

1. To determine the sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT. To evaluate the impact of [18F]F-FAPI PET-CT on further diagnostics and potential treatments, including accompanying burden/costs/timelines, outcomes and advantages with regard to the establishment of a primary tumor diagnosis.  To evaluate safety and tolerability of [18F]F-FAPI PET-CT.  To analyse possible incidental findings on [18F]F-FAPI PET-CT.  To compare [18F]F-FAPI and [18F]FDG uptake patterns.  To perform subgroup analyses for the primary and secondary endpoints based on sex, age (<65 vs. >65 years), tumor histology, site of metastasis and performance status (applicable if n>10 per subgroup).  To perform an overall descriptive analysis of patients who dropped out prior to [18F]F-FAPI PET-CT, such as due to the detection of a primary tumor during the inclusion reading of the [18F]FDG PETCT.  To perform an inter-patient comparison of the head and neck [18F]F-FAPI PET-CT with the neck scan of the whole body [18F]F-FAPI PET-CT.

Conditions and MedDRA coding

Carcinoma of Unknown Primary

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Age ≥ 18 years old
2. Histologically-confirmed metastatic disease without identification of a primary tumor after standard diagnostic work-up, according to the national care pathway for CUP (in Dutch: Regionaal Zorgpad Primaire Tumor Onbekend), which includes at least a [18F]FDG PET-CT.

Exclusion criteria 11

1. Patients with metastasis from a known primary tumor.
2. Sarcomas, melanomas, germ cell tumors, neuroendocrine tumors and haematological malignancies whose exact site of origin is not established.
3. History of malignancy within 5 years prior to [18F]F-FAPI PET-CT scan, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%), such as adequately treated carcinoma in-situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in-situ, or Stage I uterine cancer.
4. Prior systemic therapy for the treatment of CUP.
5. Radiotherapy prior to [18F]F-FAPI PET-CT. Off note: radiotherapy with palliative intent for symptomatic skeleton lesions is allowed.
6. Impaired renal function, defined as eGFR (MDRD) <25 ml/min/1,73 m2. An exception can be made in consultation with the treating physician.
7. WHO performance status >2 (Vademecum).
8. Pregnancy/breastfeeding. For the latter, temporary discontinuation may be considered.
9. Known allergic reaction to therapeutic radiopharmaceuticals
10. Inability to lie still on the back for the duration of PET-CT
11. Any (other) condition, disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that may affect the interpretation of the results, or which might contribute substantially to the patient's experience of study burden (such as non-suppressible claustrophobia)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The proportion of CUP patients in whom the primary tumor is identified by [18F]F-FAPI PET-CT (i.e., the correct detection rate).

Secondary endpoints 1

1. Sensitivity, specificity, positive- and negative predictive value of [18F]F-FAPI PET-CT.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

S.E.M. Veldhuijzen van Zanten

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

E. Droogers

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications