Clinical trial · Interventional
Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
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
NCT05262855CI-TRIAL-00113021FAPI-46 PDACcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| FAP | — | UNRESOLVED | — |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]FAPI-46 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI-46 PET/CT
- description
- Patients receive \[68Ga\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later
- interventionNames
- Drug: [68Ga]FAPI-46
Primary outcomes (1)
- measure
- Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard
- timeFrame
- Day 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed pancreatic ductal adenocarcinoma 2. Treatment-naïve 3. Staged as resectable or borderline-resectable 4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection 5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent 6. Age ≥ 18 years 7. Completed informed consent as determined per the IRB of record Exclusion Criteria: 1. Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential 2. Declining to use effective contraceptive methods during the study (for individuals of child-producing potential) 3. Need for emergent surgery that would be delayed by participation 4. Bacterial, viral, or fungal infections requiring systemic therapy 5. 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. 6. Known diagnosis of autoimmune disorders 7. Patients receiving any other investigational agent within the past 28 days 8. 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. 9. Known hypersensitivity to any excipients used in \[68Ga\]FAPI-46: trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid
References
Publications (1)
- DERIVEDKarbhari 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. PMID 38011131