Clinical trial NCT05262855: Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: PDAC - Pancreatic Ductal Adenocarcinoma
FAP
Keywords: Fibroblast Activation Protein Inhibitor (FAPI)
PDAC
Lead sponsor: SOFIE
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.
timeFrame: Through study completion, 2 years
Secondary outcomes:
measure: Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.
timeFrame: Through study completion, 2 years
measure: Histopathology with FAP staining on FAP IHC assay.
timeFrame: Through study completion, 2 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: Up to 24 hours post injection with [68Ga]FAPI-46
measure: [68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.
timeFrame: Through study completion, 2 years
measure: [68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.
timeFrame: Through study completion for patient undergoing Neoadjuvant treatment, 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles (UCLA) Health
state: California
city: Grand Rapids
country: United States
facility: BAMF Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References: