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

14. september 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

71

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Italia
    • Lombardy
      • Bergamo, Lombardy, Italia, 24127
        • Rekruttering
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
        • Ta kontakt med:
          • Paola Erba
      • Monza, Lombardy, Italia, 20900
        • Rekruttering
        • Fondazione IRCCS San Gerardo dei Tintori
        • Ta kontakt med:
          • Luca Guerra
    • Roma
      • Roma, Roma, Italia, 00136
        • Har ikke rekruttert ennå
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
        • Ta kontakt med:
          • Salvatore Annunziata
    • Segrate
      • Milan, Segrate, Italia, 20132
        • Rekruttering
        • IRCCS Ospedale San Raffaele
        • Ta kontakt med:
          • Arturo Chiti
  • Nederland
      • Groningen, Nederland, 9713
        • Rekruttering
        • University Medical Center Groningen
        • Ta kontakt med:
          • Erik Aarntzen
      • Nijmegen, Nederland, 6525
        • Rekruttering
        • Stichting Radboud Universitair Medisch Centrum
        • Ta kontakt med:
          • Martin Gotthardt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: [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).
Legemiddel: [68Ga]BED003
Positron emission tomography (PET)/computed tomography (CT) imaging

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Further assess the diagnostic performance of [68Ga]BED003.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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).
Tidsramme: 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).
Tidsramme: Immediately following administration of [68Ga]BED003
Reader assessments of diagnostic quality based on simulated reduced count data.
Immediately following administration of [68Ga]BED003

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Blue Earth Diagnostics

Samarbeidspartnere

Medpace, Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2026

Primær fullføring (Antatt)

1. februar 2028

Studiet fullført (Antatt)

1. februar 2028

Datoer for studieregistrering

Først innsendt

30. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. september 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BED-FAP-201
  • 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521983-36-00 (Ctis)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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