NCT07629609

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
5mo left

Started Jan 2024

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2024Jan 2027

Study Start

First participant enrolled

January 16, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

3 years

First QC Date

September 10, 2025

Last Update Submit

June 1, 2026

Conditions

Gastroesophageal Cancer (GC)Pancreatic Cancer, Adult

Keywords

PET/CTFAPIpancreatic cancergastroesophageal cancersignet ring cell carcinoma

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of [68Ga]Ga-FAPI-46 Total Body PET/CT

    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

Secondary Outcomes (3)

  • Accuracy measurements of [68Ga]Ga-FAPI-46 Total Body PET/CT

    From the time of scan to the end of follow up at 1 year

  • Estimated potential impact/change in patient management.

    From the time of scan to the end of follow up at 1 year

  • Description of FAPI-uptake from lesions suspicious of malignancy.

    From the time of scan to the end of follow up at 1 year

Other Outcomes (2)

  • Patients' experience of a [68Ga]Ga-FAPI-46 Total Body PET/CT compared to standard imaging modalities.

    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)

    From the time of scan to the end of follow up at 1 year

Study Arms (1)

Cancer patients

EXPERIMENTAL
Drug: [68Ga]Ga-FAPI-46

Interventions

[68Ga]Ga-FAPI-46DRUG

PET/CT scan with the tracer \[68Ga\]Ga-FAPI-46

Cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, over 18 years old
  • Patients with suspected pancreatic cancer based on morphological findings on standard imaging
  • CT or MRI or \[18F\]FDG PET/CT evaluated on MDT with no initial sign of distant metastases
  • Subjects must have been considered suitable for curative surgery at the time of the referral
  • Subjects must be able to read and understand the patient information in Danish to give informed consent
  • Male or female over 18 years old
  • Histological verified carcinoma from the lower esophagus, GEJ, or stomach
  • Subjects must be considered operable and resectable at the time of referral for MDT
  • Subjects must be able to read and understand the patient information in Danish to give informed consent
  • Male or female over 18 years old
  • Histological verified SRCC or PCC from the lower esophagus, GEJ, or stomach
  • Subjects with localized disease assigned to perioperative chemotherapy or subjects with metastatic disease assigned to palliative systemic treatment.
  • Subjects must be able to read and understand the patient information in Danish to give informed consent

You may not qualify if:

  • Pregnancy or lactation
  • Weight more than the maximum limit of a PET/CT-scanner bed (140 kg)
  • History of allergic reaction due to compounds similar to the chemical composition of \[68Ga\]Ga-FAPI-46

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Pancreatic cancer, adultPancreatic NeoplasmsCarcinoma, Signet Ring Cell

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Cystic, Mucinous, and Serous

Central Study Contacts

Marie M K Stolberg, MD

CONTACT

+4535454416marie.manon.krebs.krarup@regionh.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, Ph.D.

Study Record Dates

First Submitted

September 10, 2025

First Posted

June 5, 2026

Study Start

January 16, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)