Gastrointestinal CancersPhase 218F-FAPI-74 GINCT05641896
Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
A Phase 2 study testing [18F]FAPI-74 PET/CT in people with Gastrointestinal Cancers and Cholangiocarcinoma, run by SOFIE at 6 sites in United States.
Trial summary
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer
- What is being tested?
- [18F]FAPI-74 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 6 sitesUnited States
- Study dates
- 28 Apr 2023to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
- Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
- No treatment received between tissue sample taken and [18F]FAPI-74 PET
- Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
- Age ≥ 18 years
- Completed informed consent as determined per the IRB of record
Who cannot join
- Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
- Need for emergent surgery that would be delayed by participation
- Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
- Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
- Known diagnosis of an autoimmune disorder that is expected to impact FAP expression in the opinion of the sponsor or their designee
Show all 10Show fewer
- Patients receiving any other investigational agent within the past 28 days
- Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [18F]FAPI-74 injection
- Known hypersensitivity to any excipients used in [18F]FAPI-74: trace amounts of sodium acetate, sodium ascorbate, ascorbic acid, ethanol, acetonitrile or AlCl.
- Renal or liver function impairment* *Defined by liver impairments as AST>3x the upper limit of normal, ALT>3x the upper limit of normal, or bilirubin>1.5x the upper limit of normal. Renal impairment as defined by a creatinine clearance of >1.5x the upper limit of normal utilizing the Cockcroft Gault formula
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts general hospital
Boston, Massachusetts, 02114
BAMF Health
Grand Rapids, Michigan, 49503
Northwell Health
Lake Success, New York, 11042
University of California Los Angeles (UCLA) Health
Los Angeles, California, 90095
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, 10065
Mayo Clinic Rochester
Rochester, Minnesota, 55902
About this study
Official title: A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.
- Conditions
- Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Hepatocellular Carcinoma
- Being tested
- [18F]FAPI-74 PET/CT
- Keywords
- Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Cholangiocarcinoma, Stomach Neoplasms, Colorectal Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FAPI-74 PET/CTDrug
[18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastrointestinal cancers.
| Study group | Role | What they receive |
|---|---|---|
| [18F]FAPI-74 PET/CT | Experimental | Patients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later Receives: Drug: [18F]FAPI-74 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of [18F]FAPI-74 PET Imaging Using Immunohistochemistry (IHC)
The positive or negative status according to [18F]FAPI-74 PET imaging was determined based on a prespecified cut-off value for each appropriate test as determined by the clinician. Positivity was evaluated using the following prespecified H-score thresholds: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only. The primary efficacy endpoint was the positive predictive value of [18F]FAPI-74 PET imaging, defined as the proportion of PET-positive results that were confirmed positive by IHC. PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Measured: Day 1
Sensitivity of [18F]FAPI-74 PET Imaging to Detect FAP-Expressing Cells, Using IHC
Sensitivity was defined as the proportion of participants with IHC confirmed FAP-expressing cells who had a positive [18F]FAPI-74 PET result for the primary lesion. Sensitivity was calculated as A / (A + C), where A represents true positive findings and C represents false negative findings. Higher sensitivity indicates a greater ability of [18F]FAPI-74 PET to detect IHC confirmed FAP expression and a lower likelihood of false negative results, thereby reflecting the effectiveness of the imaging modality relative to the IHC reference standard. Sensitivity was presented overall for all IHC-positive results and separately using stricter IHC cut-off values categorized as: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
Measured: Day 1
Specificity of [18F]FAPI-74 PET Imaging to Detect Absence of FAP-Expressing Cells, Using IHC as Truth Standard
Specificity was defined as the proportion of participants without IHC-confirmed FAP-expressing cells who had a negative [18F]FAPI-74 PET result for the primary lesion. Specificity was calculated by comparing positive and negative [18F]FAPI-74 PET findings with the corresponding IHC results, using a single readable PET image matched to its reference IHC assessment. Specificity was calculated as D / (B + D), where B represents false-positive findings and D represents true-negative findings. PET results were compared with the corresponding IHC reference assessment using a single readable PET image per participant. Specificity was evaluated overall using IHC negativity defined as > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
Measured: Day 1
Secondary outcomes (3)
PPV of [18F]FAPI-74 PET Images to Detect Cancer Cells Using Histopathology as Truth Standard
Positive Predictive Value (PPV) of [18F]FAPI-74 PET imaging in detecting presence of disease using histopathology as the truth standard. The PPV is defined as the probability that one is indeed positive for an outcome given that they test positive for the outcome and is calculated as: PPV = A/(A + B), where A represents true-positive findings and B represents false-positive findings (PET positive but histopathology negative). PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Measured: Day 1
Sensitivity of [18F]FAPI-74 PET Imaging to Detect Cancers Cells, Using Histopathology as Truth Standard
Sensitivity was defined as the proportion of participants with histopathology-confirmed cancers cells who had a positive [18F]FAPI-74 PET result for the primary lesion. Sensitivity was calculated by comparing positive and negative [18F]FAPI-74 PET findings with the corresponding histopathology results, using a single readable PET image matched to its reference histopathology assessment. Sensitivity was calculated as A / (A + C), where A represents true-positive findings and C represents false-negative findings. Sensitivity was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Measured: Day 1
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) is any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.
A TEAE is defined as any untoward medical occurrence that begins or worsens in intensity or frequency after the initiation of a treatment (e.g., drug, device, or procedure) in a clinical study.
A serious TEAE is defined as any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization.
Measured: From study intervention administration (Day 1) to 72 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start28 Apr 2023
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- SOFIE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641896
- Sponsor's protocol ID
- 18FFAPI-2023P2
- Acronym
- 18F-FAPI-74 GI
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2022
- Last updated
- 1 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Single Arm, Open Label, Non-Randomized Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers
- ClinicalTrials.gov ID
- NCT05641896
- Acronym / sponsor ID
- 18F-FAPI-74 GI / 18FFAPI-2023P2
- Conditions
- Gastrointestinal Cancers, Cholangiocarcinoma, Gastric Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Hepatocellular Carcinoma
- Keywords
- Fibroblast Activation Protein, Fibroblast Activation Protein Inhibitor, FAPI, Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- SOFIEIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Posted 1 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multi-center, open label, non-randomized clinical trial to assess efficacy of [18F]FAPI-74 to detect FAP expressing cells in patients diagnosed with gastrointestinal cancers, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer. The [18F]FAPI-74 PET scan will be acquired in patients with proven GI cancers after initial staging using institutional standard methods. The PET scan results will be compared to FAP immunohistochemistry (as the primary objective) and histopathology (as the secondary objective) of the biopsied or resected tissues.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FAPI-74 PET/CT | Experimental | Drug: [18F]FAPI-74 PET/CTPatients receive [18F]FAPI-74 intravenously followed by PET/CT 60 minutes (+/-10minutes) later |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed diagnosis of gastrointestinal (GI) malignancy, including hepatocellular carcinoma, cholangiocarcinoma, gastric, pancreatic and colorectal cancer
- Available tissue sample obtained through biopsy or to be obtained through scheduled biopsy and/or surgical resection
- No treatment received between tissue sample taken and [18F]FAPI-74 PET
- Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
- Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
- Need for emergent surgery that would be delayed by participation
- Bacterial, viral, or fungal infections requiring systemic therapy, that are expected to impact FAP expression in the opinion of the sponsor or their designee
- Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise subject safety and/or protocol objectives
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FAPI-74 PET/CT[18F]FAPI-74 is a radioactive diagnostic agent indicated for use with Positron Emission Tomography (PET) imaging for the detection of Fibroblast Activation Protein (FAP) positive cancer cells and cancer-associated fibroblasts (CAF) in patients with gastrointestinal cancers. | Drug | [18F]FAPI-74 PET/CT |
Primary outcome
Positive Predictive Value (PPV) of [18F]FAPI-74 PET Imaging Using Immunohistochemistry (IHC)
Time frame: Day 1
The positive or negative status according to [18F]FAPI-74 PET imaging was determined based on a prespecified cut-off value for each appropriate test as determined by the clinician. Positivity was evaluated using the following prespecified H-score thresholds: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only. The primary efficacy endpoint was the positive predictive value of [18F]FAPI-74 PET imaging, defined as the proportion of PET-positive results that were confirmed positive by IHC. PPV was summarized using proportions along with two-sided 95% asymptotic normal confidence intervals.
Sensitivity of [18F]FAPI-74 PET Imaging to Detect FAP-Expressing Cells, Using IHC
Time frame: Day 1
Sensitivity was defined as the proportion of participants with IHC confirmed FAP-expressing cells who had a positive [18F]FAPI-74 PET result for the primary lesion. Sensitivity was calculated as A / (A + C), where A represents true positive findings and C represents false negative findings. Higher sensitivity indicates a greater ability of [18F]FAPI-74 PET to detect IHC confirmed FAP expression and a lower likelihood of false negative results, thereby reflecting the effectiveness of the imaging modality relative to the IHC reference standard. Sensitivity was presented overall for all IHC-positive results and separately using stricter IHC cut-off values categorized as: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
Specificity of [18F]FAPI-74 PET Imaging to Detect Absence of FAP-Expressing Cells, Using IHC as Truth Standard
Time frame: Day 1
Specificity was defined as the proportion of participants without IHC-confirmed FAP-expressing cells who had a negative [18F]FAPI-74 PET result for the primary lesion. Specificity was calculated by comparing positive and negative [18F]FAPI-74 PET findings with the corresponding IHC results, using a single readable PET image matched to its reference IHC assessment. Specificity was calculated as D / (B + D), where B represents false-positive findings and D represents true-negative findings. PET results were compared with the corresponding IHC reference assessment using a single readable PET image per participant. Specificity was evaluated overall using IHC negativity defined as > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.
3 secondary outcomes
PPV of [18F]FAPI-74 PET Images to Detect Cancer Cells Using Histopathology as Truth Standard
Time frame: Day 1
Sensitivity of [18F]FAPI-74 PET Imaging to Detect Cancers Cells, Using Histopathology as Truth Standard
Time frame: Day 1
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From study intervention administration (Day 1) to 72 hours post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]FAPI-74 PET/CT in people with Gastrointestinal Cancers and Cholangiocarcinoma, run by SOFIE at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) of [18F]FAPI-74 PET Imaging Using Immunohistochemistry (IHC) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.