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

14 september 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

71

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: [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).
Geneesmiddel: [68Ga]BED003
Positron emission tomography (PET)/computed tomography (CT) imaging

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Assess the diagnostic performance of [68Ga]BED003 in the peritoneum.
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Further assess the diagnostic performance of [68Ga]BED003.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: Immediately following administration of [68Ga]BED003
Reader assessments of diagnostic quality based on simulated reduced count data.
Immediately following administration of [68Ga]BED003

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Blue Earth Diagnostics

Medewerkers

Medpace, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 juni 2026

Primaire voltooiing (Geschat)

1 februari 2028

Studie voltooiing (Geschat)

1 februari 2028

Studieregistratiedata

Eerst ingediend

30 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

14 september 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BED-FAP-201
  • 2025 (Subsidie/contract van de Amerikaanse NIH: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-521983-36-00 (Ctis)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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