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BEFAST Study, [68Ga]Ga-FAPI Total Body PET/CT for Better and Faster Imaging in Cancer (BEFAST)

1 juin 2026 mis à jour par: Barbara Malene Fischer

[68Ga]Ga-FAPI Total Body PET/CT for Improving Diagnostic Sensitivity and Preoperative Staging in Gastroesophageal Cancer and Pancreatic Cancer

The goal of this clinical trial is to learn if [68Ga]Ga-FAPI-46 Total Body PET/CT can diagnose patients suffering from gastroesophageal cancer and pancreatic cancer. The investigators hope that [68Ga]Ga-FAPI-46 Total Body PET/CT can improve staging and treatment evaluation for these patient groups.

The main questions the trial aims to answer are:

  • Is [68Ga]Ga-FAPI-46 Total Body PET/CT better at diagnosing metastatic disease in the abdomen compared other imaging modalities?
  • Can [68Ga]Ga-FAPI-46 Total Body PET/CT produce accurate images in less than 30 min?

Researchers will examine three different patient groups:

Group A) patients with pancreatic cancer, who are referred to surgery. Group B1) patients with gastroesophageal cancer, who are referred to diagnostic surgery (laparoscopy).

Group B2) a subgroup of gastroesophageal cancer patients, with a specific subtype cancer (signet ring cell carcinoma or poorly cohesive carcinoma), who are referred to oncological treatment.

Participants will undergo:

  • One [68Ga]Ga-FAPI Total Body PET/CT before surgery (Group A), or before laparoscopy (group B1), or before oncological treatment (Group B2).
  • Participants in group B2 will also undergo a second [68Ga]Ga-FAPI-46 Total Body PET/CT during treatment with chemotherapy.
  • All participants will fill out one questionnaire.
  • Researchers will follow the patients after the scans for 1 year.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

90

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Danemark
      • Copenhagen, Danemark, 2100
        • Recrutement
        • Rigshospitalet
        • Contact:
        • Contact:
          • Barbara M Fischer, professor, Professor, MD, Ph.D.
        • Sous-enquêteur:
          • Marie M K Stolberg, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion criteria for group A

  1. Male or female, over 18 years old
  2. Patients with suspected pancreatic cancer based on morphological findings on standard imaging
  3. CT or MRI or [18F]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
  4. Subjects must have been considered suitable for curative surgery at the time of the referral
  5. Subjects must be able to read and understand the patient information in Danish to give informed consent

Inclusion criteria for group B1

  1. Male or female over 18 years old
  2. Histological verified carcinoma from the lower esophagus, GEJ, or stomach
  3. Subjects must be considered operable and resectable at the time of referral for MDT
  4. Subjects must be able to read and understand the patient information in Danish to give informed consent

Inclusion criteria for group B2

  1. Male or female over 18 years old
  2. Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
  3. Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
  4. Subjects must be able to read and understand the patient information in Danish to give informed consent

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
  3. History of allergic reaction due to compounds similar to the chemical composition of [68Ga]Ga-FAPI-46

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Cancer patients
Médicament: [68Ga]Ga-FAPI-46
PET/CT scan with the tracer [68Ga]Ga-FAPI-46

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT
Délai: From the time of scan to the end of follow up at 1 year

Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 Total Body PET/CT within 30 min of injection of the tracer compared with the sensitivity of current standard imaging modalities ([18F]FDG PET/CT, CT, MRI).

Sensitivity will be measured as the proportion of true positive malignant findings on [68Ga]Ga-FAPI-46 Total Body PET/CT within 30 mins of injection of the tracer. This will be done, by comparing the lesions suspicious of malignancy found on [68Ga]Ga-FAPI-46 PET/CT, and standard imaging with the results from the curative surgery and/or a composed reference standard, which consist of all available imaging, 6 months follow up and blinded expert opinion.
From the time of scan to the end of follow up at 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT
Délai: From the time of scan to the end of follow up at 1 year

Sensitivity of lesions suspicious of malignancy of [68Ga]Ga-FAPI-46 Total Body PET/CT after 60 min of injection of the tracer, as well as accuracy, specificity, positive predictive value (PPV) and negative predictive value (NPV).

Sensitivity (the proportion of true positive findings), specificity (the proportion of true negative findings), PPV (the proportion of positive findings, which are true positives) and NPV (the proportion of negative findings which are true negatives will be measured by comparing the lesions suspicious of malignancy found on [68Ga]Ga-FAPI-46 PET/CT and standard imaging with the results from the curative surgery and/or a composed reference standard, which is composed of all available imaging, 6 months follow up and blinded expert opinion.
From the time of scan to the end of follow up at 1 year
Estimated potential impact/change in patient management.
Délai: From the time of scan to the end of follow up at 1 year
From the time of scan to the end of follow up at 1 year
Description of FAPI-uptake from lesions suspicious of malignancy.
Délai: From the time of scan to the end of follow up at 1 year
FAPI-uptake in lesions suspicious of malignancy will be described and quantified with standardized uptake values (SUV, e.g. SUVmax, SUVmean). SUV is a ratio of the concentration of the tracer in a region of interest on the scan and the concentration of tracer injected in the participant.
From the time of scan to the end of follow up at 1 year

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities.
Délai: Immediately after completion of the scan (single time point)
Patients will be given a small questionnaire immediately after the [68Ga]Ga-FAPI-46 TB PET/CT, to fill out by his or herself (please refer to the appendix 2 in the protocol). The questionnaire is inspired by a questionnaire from a previous study exploring patient experiences during an [18F]FDG PET/CT and with inspiration from local and national questionnaires on patient experience during visits to radiology departments provided by the Capital Region of Denmark. The questionnaire includes 6 questions, 2 regarding patient information, 3 questions regarding stress and anxiety during the exmination and 1 question regarding the expectations to the scan. The different questions is rated on a descriptive scale (Very Much, Quite a lot, Some, Not at all).
Immediately after completion of the scan (single time point)
Uptake of [68Ga]Ga-FAPI-46 from lesions suspicious of malignancy wil be correlated with progression free survival (PFS)
Délai: From the time of scan to the end of follow up at 1 year
FAPI-uptake (measured as Standardised uptake value [SUV], which is a ratio of the concentration of the tracer in a region of interest on the scan and the concentration of tracer injected in the patient) in lesions suspicious of malignancy will be correlated with PFS after 1 year follow-up. PFS is defined as the time from the [68Ga]Ga-FAPI-46 TB PET/CT to progression of cancer disease, recurrence of cancer disease, or death of any cause.
From the time of scan to the end of follow up at 1 year

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Barbara Malene Fischer

Collaborateurs

Danish Cancer Society
Herlev Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 janvier 2024

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 janvier 2027

Dates d'inscription aux études

Première soumission

10 septembre 2025

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 523_22
  • 2023-503632-41-01 (Ctis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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