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

NCT07385950 | Not Yet Recruiting

• 1 other identifier: IIT2025383
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

PET / CT; Solid Tumors; Adult

Keywords

integrin αVβ6; FAP; PET imaging; Diagnostic efficacy

Outcome Measures

Primary Outcomes (1)

• The diagnostic sensitivity and specificity of 68Ga-B6FA-01 PET/CT in the staging of malignant tumors

  To assess the he diagnostic performance of 68Ga-B6FA-01 PET/CT in patients with newly diagnosed malignancies. Accuracy will be evaluated using a composite reference standard, including histopathological confirmation, clinical follow-up, and additional imaging findings.

  3 years

Secondary Outcomes (1)

• The connection between B6FA-01 PET parameters and histopathological biomarkers.

  Within 4 weeks of B6FA-01 PET scan

Study Arms (1)

Recipients with Malignant solid tumors

Participants: Patients (≥18 years) with highly suspected or pathologically confirmed malignant tumors, or patients with suspected recurrence of malignant tumors after treatment Interventions: 68Ga-B6FA-01 PET/CT scan prior to therapy. Objectives: * Evaluate the diagnostic efficacy of 68Ga-B6FA-01 PET in malignant solid tumors. * Evaluate the safety and tolerability, biological distribution, radiation dose, and pharmacokinetic characteristics of 68Ga-B6FA-01 in cancer patients. * Evaluate the relationship between quantitative parameters of PET imaging and pathological indicators Design: Single-arm observational study; PET parameters (SUVmax, tumor-to-background ratio, et al) will be correlated with clinical outcomes.

Diagnostic Test: PET/CT Imaging with αvβ6/FAP-targeted tracer

Interventions

PET/CT Imaging with αvβ6/FAP-targeted tracer DIAGNOSTIC_TEST

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

Recipients with Malignant solid tumors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants must voluntarily enroll and provide written informed consent, be aged 18 to 90 years (inclusive) regardless of gender, and have a pathologically confirmed diagnosis of treatment-naïve malignant solid tumors or suspected of having a recurrence after treatment. Additionally, participants must demonstrate willingness and ability to comply with scheduled clinical visits.

You may qualify if:

• Voluntarily provide written informed consent.
• Age ≥ 18 years.
• Newly diagnosed with a clinically/radiologically suspected or pathologically confirmed malignant solid tumor, or with suspected recurrence after prior treatment.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
• Life expectancy \> 6 months.
• Participants of childbearing potential and their partners must agree to use highly effective contraception for 6 months following the last dose of the investigational agent.

You may not qualify if:

• Prior radioisotope therapy within an interval less than 10 times the physical half-life of the respective radionuclide before study administration.
• Concurrent participation in any other interventional clinical trial.
• Known allergy or hypersensitivity to the investigational agent or any of its excipients.
• Inability to lie still for the duration of the PET scan or any condition contraindicating PET imaging.
• Pregnancy or lactation.
• Any other condition that, in the investigator's judgment, would compromise participant safety or study integrity.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Related Publications (1)

• Zang J, Wen X, Lin R, Zeng X, Wang C, Shi M, Zeng X, Zhang J, Wu X, Zhang X, Miao W, Xu P, Guo Z, Zhang J, Chen X. Synthesis, preclinical evaluation and radiation dosimetry of a dual targeting PET tracer [68Ga]Ga-FAPI-RGD. Theranostics. 2022 Oct 9;12(16):7180-7190. doi: 10.7150/thno.79144. eCollection 2022.

  PMID: 36276644 BACKGROUND

Study Officials

• Yong He, MD, PhD

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong He, MD, PhD

CONTACT

+86-27-67812698; heyong@whu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nuclear Medicine, Zhongnan Hospital of Wuhan University

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 4, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

CN (1)