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

14 de septiembre de 2026 actualizado por: 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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

71

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Italia
    • Lombardy
      • Bergamo, Lombardy, Italia, 24127
        • Reclutamiento
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
        • Contacto:
          • Paola Erba
      • Monza, Lombardy, Italia, 20900
        • Reclutamiento
        • Fondazione IRCCS San Gerardo dei Tintori
        • Contacto:
          • Luca Guerra
    • Roma
      • Roma, Roma, Italia, 00136
        • Aún no reclutando
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Contacto:
          • Salvatore Annunziata
    • Segrate
      • Milan, Segrate, Italia, 20132
        • Reclutamiento
        • IRCCS Ospedale San Raffaele
        • Contacto:
          • Arturo Chiti
  • Países Bajos
      • Groningen, Países Bajos, 9713
        • Reclutamiento
        • University Medical Center Groningen
        • Contacto:
          • Erik Aarntzen
      • Nijmegen, Países Bajos, 6525
        • Reclutamiento
        • Stichting Radboud Universitair Medisch Centrum
        • Contacto:
          • Martin Gotthardt

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: [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).
Droga: [68Ga]BED003
Positron emission tomography (PET)/computed tomography (CT) imaging

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Further assess the diagnostic performance of [68Ga]BED003.
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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).
Periodo de tiempo: 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).
Periodo de tiempo: Immediately following administration of [68Ga]BED003
Reader assessments of diagnostic quality based on simulated reduced count data.
Immediately following administration of [68Ga]BED003

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Blue Earth Diagnostics

Colaboradores

Medpace, Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

30 de junio de 2026

Finalización primaria (Estimado)

1 de febrero de 2028

Finalización del estudio (Estimado)

1 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

30 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

10 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BED-FAP-201
  • 2025 (Subvención/contrato del NIH de EE. UU.: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521983-36-00 (Ctis)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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