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Evaluation of the Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors

NCT07385950 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-02-04

No results posted yet for this study

Summary

Malignant tumors pose a grave threat to human health and impose a substantial burden on society. Molecular imaging, which enables non-invasive, in vivo visualization of biological processes at the molecular level, is crucial for early diagnosis and treatment monitoring, thereby improving clinical management. Currently, molecular probes targeting fibroblast activation protein (FAP) and integrin αvβ6, such as ⁶⁸Ga-labeled FAPI and ⁶⁸Ga-Trivehexin, have shown promise in oncologic PET imaging, yet each has limitations.

FAP is predominantly overexpressed in cancer-associated fibroblasts within the tumor stroma, with minimal expression in normal tissues. However, radiotracers like ⁶⁸Ga-FAPI often exhibit physiological uptake in normal organs (e.g., salivary glands, pancreas, uterus), leading to elevated background signals and potentially reduced diagnostic contrast. Conversely, integrin αvβ6 is primarily expressed on tumor cell surfaces and is upregulated in many malignancies. Nonetheless, probes like ⁶⁸Ga-Trivehexin suffer from high renal retention with slow clearance and notable physiological gastrointestinal uptake, resulting in suboptimal target-to-background ratios and compromised image quality.

Given the complementary expression profiles of FAP (stroma) and integrin αvβ6 (tumor cells), we hypothesize that a bispecific molecular probe capable of simultaneously engaging both targets could achieve superior tumor targeting through a synergistic "dual-lock" mechanism. This prospective exploratory clinical trial aims to evaluate the diagnostic efficacy and safety of a novel bispecific probe, named ⁶⁸Ga-B6FA-01, in patients with malignant solid tumors. The ultimate goal is to develop a superior imaging strategy for early and precise tumor diagnosis, treatment response assessment, and personalized therapeutic decision-making.

Conditions

Interventions

DIAGNOSTIC_TEST

PET/CT Imaging with αvβ6/FAP-targeted tracer

Intravenous administration of αvβ6/FAP-targeted tracer (111\~185 MBq), followed by whole-body PET/CT scan 30\~60 minutes post-injection.

Sponsors & Collaborators

  • Zhongnan Hospital

    lead OTHER

Principal Investigators

  • Yong He, MD, PhD · Zhongnan Hospital

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07385950 on ClinicalTrials.gov