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

1 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

90

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 Locaties

  • Denemarken
      • Copenhagen, Denemarken, 2100
        • Werving
        • Rigshospitalet
        • Contact:
        • Contact:
          • Barbara M Fischer, professor, Professor, MD, Ph.D.
        • Onderonderzoeker:
          • Marie M K Stolberg, MD

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 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

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: Cancer patients
Geneesmiddel: [68Ga]Ga-FAPI-46
PET/CT scan with the tracer [68Ga]Ga-FAPI-46

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities.
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

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

Sponsor

Barbara Malene Fischer

Medewerkers

Danish Cancer Society
Herlev Hospital

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)

16 januari 2024

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

10 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

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

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

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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