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PDAC - Pancreatic Ductal AdenocarcinomaPhase 2FAPI-46 PDACNCT05262855

Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma

A Phase 2 study testing [68Ga]FAPI-46 in people with PDAC - Pancreatic Ductal Adenocarcinoma and FAP, run by SOFIE at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PDAC - Pancreatic Ductal Adenocarcinoma, FAP
What is being tested?
[68Ga]FAPI-46
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
4 sitesUnited States
Study dates
2 May 2022to 4 Nov 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

  • Pathologically confirmed pancreatic ductal adenocarcinoma
  • Treatment-naïve
  • Staged as resectable or borderline-resectable
  • Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
  • 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
  • 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 patient safety and/or protocol objectives.
  • Known diagnosis of autoimmune disorders
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  • 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 [68Ga]FAPI-46 injection.
  • Known hypersensitivity to any excipients used in [68Ga]FAPI-46:
  • trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • BAMF Health

    Grand Rapids, Michigan, 49503

  • University of California Los Angeles (UCLA) Health

    Los Angeles, California, 90095

  • NYU Langone Health

    New York, New York, 10016

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase 2, Multicenter, Single Arm, Open Label Non-Randomized Study of [68Ga]FAPI-46 PET in Patients With Resectable or Borderline Resectable Pancreatic Ductal Carcinoma

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of [68Ga]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The [68Ga]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second [68Ga]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Being tested
[68Ga]FAPI-46
Keywords
Fibroblast Activation Protein Inhibitor (FAPI), PDAC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]FAPI-46Drug

    [68Ga]-FAPI-46 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 pancreatic ductal adenocarcinoma (PDAC).

Study groups in NCT05262855
Study groupRoleWhat they receive
68Ga-FAPI-46 PET/CTExperimentalPatients receive [68Ga]FAPI-46 intravenously followed by PET/CT 15-25 minutes later
Receives: Drug: [68Ga]FAPI-46

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard

    Sensitivity was defined as the proportion of participants with histopathology-confirmed PDAC who had a positive [⁶⁸Ga]FAPI-46 PET result for the primary lesion. Sensitivity was calculated by comparing positive and negative [⁶⁸Ga]FAPI-46 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. Higher sensitivity indicates a greater ability of [⁶⁸Ga]FAPI-46 PET to detect FAP-expressing disease and a lower likelihood of false-negative results, thereby reflecting the effectiveness of the imaging modality relative to the histopathological reference standard.

    Measured: Day 1

Secondary outcomes (4)

  1. Correlation Between [⁶⁸Ga]FAPI-46 PET Uptake (SUVmax) and IHC Staining Intensity (H-score) in FAP-positive Lesions

    The association between [⁶⁸Ga]FAPI-46 PET uptake, measured by maximum standardized uptake value (SUVmax), and FAP expression, assessed by H-score from histopathology, was evaluated. The relationship between SUVmax and H-score was assessed using the Spearman rank correlation coefficient, with corresponding 95% confidence intervals, in participants with evaluable PET imaging and histopathology results may not be linear owing in part to the H score ceiling of 300. All available paired PET and H-score measurements were included; when both pre- and post-neoadjuvant therapy data were available, each time point was analyzed separately. Spearman's rho was selected because it assesses monotonic relationships between ordinal or continuous variables and does not assume linearity, which may not be appropriate for the relationship between SUVmax and H-score.

    Measured: Day 1

  2. Sensitivity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth

    Sensitivity was defined as the proportion of participants with IHC confirmed FAP-expressing cells who had a positive [68Ga]FAPI-46 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 [68Ga]FAPI-46 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 considering IHC-positive results using 3 IHC cut-off values: > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.

    Measured: Day 1

  3. Specificity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth

    Specificity was defined as the proportion of participants without IHC-confirmed FAP-expressing cells who had a negative [68Ga]FAPI-46 PET result for the primary lesion. Specificity was calculated by comparing positive and negative [68Ga]FAPI-46 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 considering IHC-positive results using 3 IHC cut-off values > 50: Overall positive versus negative expression; > 100: Moderate to high expression and > 200: High expression only.

    Measured: Day 1

  4. Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs

    An AE is any untoward medical occurrence in a clinical study participant whether or not considered related to the study intervention. A TEAE is any AE that occurs after receipt of one or more doses of study drug through the end of study for that participant. A SAE is defined as any untoward medical occurrence that, at any dose: results in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent disability/incapacity or is a congenital anomaly/birth defect or is a medically significant / important event or reaction.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start2 May 2022
  3. Primary completion7 Mar 2025
  4. Study completion4 Nov 2025

Resources

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
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262855
Sponsor's protocol ID
GaFAPI-2022P2
Acronym
FAPI-46 PDAC
Status last verified
May 2026
First submitted
10 Feb 2022
Last updated
29 May 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Karbhari A, Mosessian S, Trivedi KH, Valla F Jr, Jacobson M, Truty MJ, Patnam NG, Simeone DM, Zan E, Brennan T, Chen H, Kuo PH, Herrmann K, Goenka AH. Gallium-68-labeled fibroblast activation protein inhibitor-46 PET in patients with resectable or borderline resectable pancreatic ductal adenocarcinoma: A phase 2, multicenter, single arm, open label non-randomized study protocol. PLoS One. 2023 Nov 27;18(11):e0294564. doi: 10.1371/journal.pone.0294564. eCollection 2023.

    PubMed 38011131

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [68Ga]FAPI-46 in people with PDAC - Pancreatic Ductal Adenocarcinoma and FAP, run by SOFIE at 4 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 7 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 29 May 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?

Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262855, which also lists 1 linked publication.

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 29 May 2026.

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