Clinical trial · Observational
Integrin αvβ6-targeted PET in Malignant Tumors
A Single-arm, Open-label, Single-center Clinical Study to the Evaluation of Integrin αvβ6-targeted Positron Emission Tomography (PET) for Malignant Tumors
NCT05835570CI-TRIAL-00089108recruitingClinicalTrials.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)
Malignant tumors are a significant health threat with high incidence and mortality rates, and molecular imaging is crucial for early diagnosis, staging, prognosis evaluation, and therapeutic efficacy assessment. 18F-FDG PET imaging is widely used, but has limitations. Integrin αvβ6 is a promising target for tumor-targeted imaging, as it is only expressed in cancerous or reconstructed epithelial cells. A new PET probe, 68Ga-Trivehexin, targeting integrin αvβ6 has been developed with better affinity and selectivity than previous probes. Clinical data supports its safety and metabolic stability, and future research will explore its diagnostic and staging value in different types of tumors, providing a new and precise evaluation method for malignant tumors.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Metastatic | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| 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
- Integrin αvβ6-targeted PET in malignant tumors
- description
- Participants: newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer. Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week. Interventions: Participant who conforms to the inclusion criteria will undergo 18F-FDG and 68Ga-Trivehexin PET/CT scans within 1 week. Objectives: This study aims to assess and compare the diagnostic performance of 68Ga-Trivehexin and 18F-FDG PET/CT for the detection of primary tumors, mediastinal lymph nodes and distant metastases, and to explore the correlation between 68Ga-Trivehexin accumulation and immunohistochemical β6 expression in NSCLC.
- interventionNames
- Diagnostic Test: PET/CT scans
Primary outcomes (1)
- measure
- The diagnostic sensitivity and specificity of 68Ga-Integrin αvβ6 PET/CT in the staging of malignant tumors
- timeFrame
- 2 years
- description
- The diagnostic performance of \[68Ga\]Ga-Trivehexin PET/CT and \[18F\]-FDG PET/CT for initial staging will be evaluated and compared using histopathological findings or typical imaging features as reference standard.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with newly diagnosed malignant tumor confirmed by pathology or suspected lung cancer; * Age ≥18 years, regardless of gender; * No prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, targeted therapy, or immunotherapy) before PET/CT; * Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-1; * Female subjects of reproductive age, male subjects and their partners agree to use reliable contraceptive measures (e.g., abstinence, birth control pills, injectable contraceptives, or subcutaneous contraceptive implants) until 6 months after the completion of the study; * Participants should voluntarily consent to the clinical trial, and have the ability to understand and sign an informed consent form. Exclusion Criteria: * Known allergy to injection or its excipients; * Severe liver or renal dysfunction; * Claustrophobia or other psychiatric disorders; * History of other malignant tumors; * Participation in another clinical trial within 30 days prior to PET/CT scan; * Pregnant or breastfeeding women; * Refusal to participate or request for withdrawing from the clinical study; * Other conditions deemed unsuitable for inclusion by investigator.
References
Publications (11)
- BACKGROUNDKimura RH, Wang L, Shen B, Huo L, Tummers W, Filipp FV, Guo HH, Haywood T, Abou-Elkacem L, Baratto L, Habte F, Devulapally R, Witney TH, Cheng Y, Tikole S, Chakraborti S, Nix J, Bonagura CA, Hatami N, Mooney JJ, Desai T, Turner S, Gaster RS, Otte A, Visser BC, Poultsides GA, Norton J, Park W, Stolowitz M, Lau K, Yang E, Natarajan A, Ilovich O, Srinivas S, Srinivasan A, Paulmurugan R, Willmann J, Chin FT, Cheng Z, Iagaru A, Li F, Gambhir SS. Evaluation of integrin alphavbeta6 cystine knot PET tracers to detect cancer and idiopathic pulmonary fibrosis. Nat Commun. 2019 Oct 14;10(1):4673. doi: 10.1038/s41467-019-11863-w. PMID 31611594
- BACKGROUNDRoesch S, Lindner T, Sauter M, Loktev A, Flechsig P, Muller M, Mier W, Warta R, Dyckhoff G, Herold-Mende C, Haberkorn U, Altmann A. Comparison of the RGD Motif-Containing alphavbeta6 Integrin-Binding Peptides SFLAP3 and SFITGv6 for Diagnostic Application in HNSCC. J Nucl Med. 2018 Nov;59(11):1679-1685. doi: 10.2967/jnumed.118.210013. Epub 2018 Apr 19. PMID 29674419
- BACKGROUNDFlechsig P, Lindner T, Loktev A, Roesch S, Mier W, Sauter M, Meister M, Herold-Mende C, Haberkorn U, Altmann A. PET/CT Imaging of NSCLC with a alphavbeta6 Integrin-Targeting Peptide. Mol Imaging Biol. 2019 Oct;21(5):973-983. doi: 10.1007/s11307-018-1296-6. PMID 30671741
- BACKGROUNDHausner SH, Bold RJ, Cheuy LY, Chew HK, Daly ME, Davis RA, Foster CC, Kim EJ, Sutcliffe JL. Preclinical Development and First-in-Human Imaging of the Integrin alphavbeta6 with [18F]alphavbeta6-Binding Peptide in Metastatic Carcinoma. Clin Cancer Res. 2019 Feb 15;25(4):1206-1215. doi: 10.1158/1078-0432.CCR-18-2665. Epub 2018 Nov 6. PMID 30401687
- BACKGROUNDKeat N, Kenny J, Chen K, Onega M, Garman N, Slack RJ, Parker CA, Lumbers RT, Hallett W, Saleem A, Passchier J, Lukey PT. A Microdose PET Study of the Safety, Immunogenicity, Biodistribution, and Radiation Dosimetry of 18F-FB-A20FMDV2 for Imaging the Integrin alphavbeta6. J Nucl Med Technol. 2018 Jun;46(2):136-143. doi: 10.2967/jnmt.117.203547. Epub 2018 Feb 2. PMID 29438002