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[68Ga]BED003 PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

14 septembre 2026 mis à jour par: Blue Earth Diagnostics

A Phase 2 Study of [68Ga]BED003 for PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications

This is a multi-centre, open-label, single-arm, Phase 2 study designed to evaluate the diagnostic performance of [68Ga]BED003 in detecting colorectal cancer (CRC), gastric cancer (GC), pancreatic ductal adenocarcinoma (PDAC), invasive lobular breast cancer (ILC), and epithelial ovarian cancer (EOC).

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

71

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

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Italie
    • Lombardy
      • Bergamo, Lombardy, Italie, 24127
        • Recrutement
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
        • Contact:
          • Paola Erba
      • Monza, Lombardy, Italie, 20900
        • Recrutement
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contact:
          • Luca Guerra
    • Roma
      • Roma, Roma, Italie, 00136
        • Pas encore de recrutement
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Contact:
          • Salvatore Annunziata
    • Segrate
      • Milan, Segrate, Italie, 20132
        • Recrutement
        • IRCCS Ospedale San Raffaele
        • Contact:
          • Arturo Chiti
  • Pays-Bas
      • Groningen, Pays-Bas, 9713
        • Recrutement
        • University Medical Center Groningen
        • Contact:
          • Erik Aarntzen
      • Nijmegen, Pays-Bas, 6525
        • Recrutement
        • Stichting Radboud Universitair Medisch Centrum
        • Contact:
          • Martin Gotthardt

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:

  1. Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.
  2. Participants must be ≥ 18 years and < 80 years of age and competent to give informed consent.
  3. Eastern Cooperative Oncology Group performance status ≤ 2.

  4. Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to [68Ga]BED003 administration.

    Note: If combining screening (Visit 1) and the PET/CT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.

  5. WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).

  6. Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).

    Note: Invasive breast cancer with mixed ductal/lobular histology is permitted.

  7. Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before [68Ga]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.

  8. Either:

    1. Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.
    2. Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.
    3. Suspected recurrence after definitive therapy.

Exclusion Criteria:

  1. Participants administered any radioisotope within 5 physical half-lives prior to [68Ga]BED003 administration.
  2. Participants administered any other IMP within 2 weeks or 5 half-lives, whichever is longest, prior to [68Ga]BED003 administration.
  3. Participants who have recently received any other contrast agent (< 24 hours for IV agents and < 5 days for oral agents) before the day of [68Ga]BED003 administration.
  4. Participants with a history of severe claustrophobia or panic attacks when in confined spaces.
  5. Known hypersensitivity to [68Ga]BED003 or any of its constituents.

  6. Participants with any medical condition or other circumstances at screening or in their past medical history that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or study completion, including, but not limited to, the following:

    1. Any other primary cancers that could confound the interpretation of the study results.
    2. Major surgery (such as laparoscopy/laparotomy/thoracotomy) over the 3 months preceding screening that could confound the interpretation of the study results.
    3. Serious, non-healing wound, ulcer, or bone fracture.
    4. Active hepatitis.
    5. Significant cardiac disorders including recent (in last 3 months) myocardial infarction or clinically significant electrocardiogram (ECG) findings.
  7. Known diagnosis of an autoimmune or inflammatory disorder that is expected to confound image interpretation per investigator judgement, excluding disorders directly related to the index cancer (e.g. tumour-associated pancreatitis or biliary stasis for PDAC).
  8. Medical history of abdomino-pelvic or breast irradiation in the last 3 months.
  9. Presence of any current implanted foreign material (e.g. stents, surgical clips) that may confound image interpretation per investigator judgement.
  10. Significant renal impairment, defined as an estimated glomerular filtration rate (as determined by the Modification of Diet in Renal Disease formula) below 45 mL/min/1.73m2 or a serum creatinine > 1.5 × the upper limit of normal.
  11. Female participants who are breastfeeding, unless the participant commits to pumping breast milk and discarding it from from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).

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: [68Ga]BED003
Each participant will receive [68Ga]BED003 followed by positron emission tomography (PET)/computed tomography (CT) imaging at the PET/CT imaging visit (Visit 2).
Médicament: [68Ga]BED003
Positron emission tomography (PET)/computed tomography (CT) imaging

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Délai: Until completion of follow-up procedures, up to 42 days post injection.
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Until completion of follow-up procedures, up to 42 days post injection.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Further assess the diagnostic performance of [68Ga]BED003.
Délai: Until completion of follow-up procedures, up to 42 days post injection
Participant and region level diagnostic performance (where calculable: sensitivity, specificity, positive predictive value, and negative predictive value) with [68Ga]BED003 PET/CT compared to composite SOT and participant and region level detection rates
Until completion of follow-up procedures, up to 42 days post injection
Semiquantitative assessment of [68Ga]BED003 tumour uptake.
Délai: Immediately following administration of [68Ga]BED003
Standardised uptake values and tumour-to-background ratios.
Immediately following administration of [68Ga]BED003
Evaluate the safety and tolerability of [68Ga]BED003.
Délai: From screening until safety follow-up (48 hours post injection).
Incidence and severity of adverse events using CTCAE version 5.0.
From screening until safety follow-up (48 hours post injection).
Confirm optimal timing of imaging following [68Ga]BED003 injection (first 6 participants).
Délai: Immediately following administration of [68Ga]BED003
Comparison of tumour-to-background ratios and reader assessments of diagnostic quality.
Immediately following administration of [68Ga]BED003
Confirm optimal [68Ga]BED003 administered activity (first 6 participants).
Délai: Immediately following administration of [68Ga]BED003
Reader assessments of diagnostic quality based on simulated reduced count data.
Immediately following administration of [68Ga]BED003

Collaborateurs et enquêteurs

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

Parrainer

Blue Earth Diagnostics

Collaborateurs

Medpace, Inc.

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)

30 juin 2026

Achèvement primaire (Estimé)

1 février 2028

Achèvement de l'étude (Estimé)

1 février 2028

Dates d'inscription aux études

Première soumission

30 juin 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 septembre 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BED-FAP-201
  • 2025 (Subvention/contrat des NIH des États-Unis: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521983-36-00 (Ctis)

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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