Evaluating the roLe of Multiplexed PET Imaging in the detection and staging of hepatocellulaR carcinoma and gAstro-entero-pancreatic tumors: a basket diagnostic performance study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Nantes

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

2 Feb 2026 → ongoing

Decision date (initial)

2025-08-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agence Nationale pour la Recherche

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The main objectives for each basket (HCC and GEP-NET) are:
a. Safety of the staggered injection of two radiopharmaceuticals via a single route of administration
b. Technical feasibility of the imaging reconstruction after a multiplexed PET scan
c. Evaluation of the diagnostic efficacy of multiplexed PET imaging for the detection and staging of both types of tumors compared to single-radiopharmaceutical PET imaging

Secondary objectives 4

1. To evaluate the visual quality of multiplexed image for clinical use for each basket
2. To evaluate patients’ satisfaction related to the use of multiplexed PET/CT imaging for each basket
3. To compare Ki and Vd extracted from multiplexed images with single-tracer dynamic acquisition (Exploratory analysis for patients who agreed to have dynamic whole body acquisition )
4. To evaluate whether dynamic PET/CT imaging (including multiplexed imaging) improves lesion detection compared with static PET/CT (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)

Conditions and MedDRA coding

hepatocellulaR carcinoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Men or women ≥ 18 years
2. Written informed consent
3. Affiliation with French social security system or beneficiary from such system
4. ECOG (Eastern Cooperative Oncology Group) performance ≤ 2
5. Presence of at least one morphological evaluable lesion according to RECIST 1.1 using contrast CT/MRI (must be performed within 6 months before inclusion)
6. Willing and able to follow scheduled visits and study procedure
7. Cohort 1 and 3: Child-Pugh A for cirrhotic patients (initial diagnosis, suspected relapse or progression) with histologically proven diagnosis. Albumin > 28 g/L, total bilirubin < 35 µM/L, TP>50% (except if AOD). The biopsy may have been performed at any point, without time limitations before inclusion.
8. Cohort 2: GEP-NET (initial diagnosis, suspected relapse or progression) with histologically proven with liver metastases and/or pancreatic involvement. The biopsy may have been performed at any point, without time limitations before inclusion.
9. Women must meet one of the following criteria at the time of inclusion: • present a negative pregnancy test (blood test) before receiving the first dose of test drug and use highly1 effective contraceptive measures for a duration of 6 months after the multiplexed PET Scan • or be post-menopausal (aged over 50 with amenorrhea for at least 12 months after stopping all exogenous hormone treatments); • or (if under 50 years of age) have been in amenorrhea for at least 12 months after stopping exogenous hormone treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels corresponding to post-menopausal levels; • or have undergone irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy (this operation must be documented);
10. Male patients will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan
11. Women partners will be required to use an acceptable contraceptive measure (as they will not receive the trial drug) for a duration of 6 months after the multiplexed PET Scan
12. Male partners will be required to use male contraception (condoms) for a duration of 3 months after the multiplexed PET Scan.

Exclusion criteria 8

1. Known hypersensitivity to gallium-68, fluor-18 to any excipient or derivative or to radiographic contrast agents.
2. Any major surgery within 4 weeks before enrollment.
3. Any uncontrolled significant medical, psychiatric or surgical condition or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or that would limit compliance with the objectives and assessments of the study.
4. Other known malignancies (except for fully-resected non-melanoma skin cancer or cervical cancer in situ) unless definitively treated and proven no evidence of recurrence for 2 years
5. Women who are pregnant or breastfeeding. A serum pregnancy test will be performed at the start of the study and within 48 hours prior to multiplexed PET scan for all female subjects of childbearing potential.
6. Patient under guardianship or trusteeship
7. Patient under judicial protection
8. patient unable to understand spoken or written French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Safety will be monitored after multiplexed radiopharmaceuticals administration and until 30 minutes after the end of the image acquisition. Adverse reactions (ARs) will be collected during that period of time.
2. Technical feasibility will be qualitatively assessed for each patient by the scientific committee at the time of reconstruction of each multiplex acquisition. An image free from artifacts interfering with visual interpretation will be considered as suitable for diagnostic evaluation.
3. The efficacy of multiplexed PET imaging will be assessed by the number, location and quantitative information of positive lesions using the multiplexed approach compared to lesions detected with each single-tracer PET scan. Two independent experts will evaluate both single- tracer PET scans, and the multiplexed scan in order to quantify and localize each detected lesion. All experts will be blinded to the results of the other imaging technique

Secondary endpoints 4

1. Visual scale grading of multiplexed image for quality assessment (low, acceptable,
2. Acceptability will be assessed using an ordinal scale from 1 (very uncomfortable) to 5 (very comfortable) and a one-question survey asking participants to indicate their preference between undergoing two separate single-tracer PET scans or one multiplexed PET scan
3. Ki and Vd computation on each of dynamic image acquisitions (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)
4. Tumor normalized uptake values (SUV) will be determined on each imaging PET (Exploratory analysis for patients who agreed to have dynamic whole body acquisition)

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nantes

Sponsor organisation

Centre Hospitalier Universitaire De Nantes

Address

5 Allee De L Ile Gloriette, Cs 69301 Cs 69301

City

Nantes Cedex 1

Postcode

44093

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Dr Clément BAILLY

Public contact point

Organisation

Centre Hospitalier Universitaire De Nantes

Contact name

Dr Clément BAILLY

Locations

1 EU/EEA country · 4 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 13 files

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

Application history

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