Clinical trialPhase 2Completed
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 2 May 2022
- Expected end
- 4 November 2025
- Enrollment
- 63 participants
- Sites
- 4
- Primary outcomes
- Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard
- Sponsor
- Industry
- Results posted
- 2026-05-29
- Last update
- 29 May 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity of [68Ga]FAPI-46 PET Imaging to Detect PDAC, Using Histopathology as Truth Standard [Day 1]. Number, proportion of participants (90% Confidence Interval). 68Ga-FAPI-46 PET/CT (n=58): 0.741 (0.647 to 0.836).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Correlation Between [⁶⁸Ga]FAPI-46 PET Uptake (SUVmax) and IHC Staining Intensity (H-score) in FAP-positive Lesions [Day 1]. Number, Correlation coefficient (95% Confidence Interval). 68Ga-FAPI-46 PET/CT (n=27): 0.137 (-0.257 to 0.491).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Sensitivity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth [Day 1]. Number, Proportion of participants (95% Confidence Interval). IHC Cutoff: >50: 68Ga-FAPI-46 PET/CT (n=34): 0.697 (0.540 to 0.854). IHC Cutoff: >100: 68Ga-FAPI-46 PET/CT (n=34): 0.700 (0.536 to 0.864). IHC Cutoff: >200: 68Ga-FAPI-46 PET/CT (n=34): 0.636 (0.352 to 0.921).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Specificity of [68Ga]FAPI-46 PET to Detect FAP-expressing Cells Using H-score as Standard of Truth [Day 1]. Number, Proportion of participants (95% Confidence Interval). IHC Cutoff: >50: 68Ga-FAPI-46 PET/CT (n=34): 1.000 (1.000 to 1.000). IHC Cutoff: >100: 68Ga-FAPI-46 PET/CT (n=34): 0.500 (0.010 to 0.990). IHC Cutoff: >200: 68Ga-FAPI-46 PET/CT (n=34): 0.304 (0.116 to 0.492).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs [Up to 2 years]. Count Of Participants, Participants. Any TEAE: [⁶⁸Ga]FAPI-46 PET/CT (n=58): 3. Any Serious TEAE: [⁶⁸Ga]FAPI-46 PET/CT (n=58): 1.