Clinical trial · Observational
FAP-targeted PET/NIR in Lung Malignant Tumors
Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
- 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)
Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET/fluorescence were compared and analyzed.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Therapy | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| PET/CT | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT scans | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FAP-targeted PET in lung malignant tumors
- description
- Participant who conforms to the inclusion criteria will undergo 68Ga-FAPI/EB-FAPI PET/CT scans within 1 week.
- interventionNames
- Diagnostic Test: PET/CT scans
Primary outcomes (2)
- measure
- Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy
- timeFrame
- From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)
- description
- To evaluate the accuracy of intraoperative FAP-targeted fluorescence imaging in identifying the tumor bed after neoadjuvant therapy in NSCLC patients, using histopathological assessment as the reference standard. Tumor bed regions identified by fluorescence will be compared with pathological mapping of tumor, regression bed, and residual tumor distribution.
- measure
- Diagnostic performance of preoperative FAPI PET for treatment response assessment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 70 years old; * Have complete clinical and imaging data; * Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer; * Able to retain sufficient tumor tissue for testing and research; * Sign informed consent. Exclusion Criteria: * Previously combined with other malignant tumors or received other anti-tumor treatments; * Failure to collect sufficient tumor tissue for testing and research; * The duration of neoadjuvant therapy is less than 3 cycles; * The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing; * Lack of clinical and imaging data; * There are situations where other researchers consider it inappropriate to participate in this study
References
Publications (5)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDChen K, Yang F, Shen H, Wang C, Li X, Chervova O, Wu S, Qiu F, Peng D, Zhu X, Chuai S, Beck S, Kanu N, Carbone D, Zhang Z, Wang J. Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer. Cancer Cell. 2023 Oct 9;41(10):1749-1762.e6. doi: 10.1016/j.ccell.2023.08.010. Epub 2023 Sep 7. PMID 37683638
- BACKGROUNDGangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19. PMID 33221195
- BACKGROUNDKennedy GT, Azari FS, Bernstein E, Marfatia I, Din A, Kucharczuk JC, Low PS, Singhal S. Targeted Intraoperative Molecular Imaging for Localizing Nonpalpable Tumors and Quantifying Resection Margin Distances. JAMA Surg. 2021 Nov 1;156(11):1043-1050. doi: 10.1001/jamasurg.2021.3757. PMID 34431971
- BACKGROUNDSarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3. PMID 37019717