PET / CTNCT07385950
Evaluation of the Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors
An observational study of PET / CT and Solid Tumors, run by Zhongnan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- PET / CT, Solid Tumors, Adult
- What is being tested?
- PET/CT Imaging with αvβ6/FAP-targeted tracer
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yaqun Jiang, MD, PhD, +86 27 67812698, zn004239@whu.edu.cn
About this study
Official title: Evaluation of Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors: An Open-Label, Single-Arm, Single-Center Study
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.
Read the detailed description
This investigator-initiated trial (IIT) aims to evaluate the clinical utility of positron emission tomography (PET) imaging targeting both integrin αvβ6 and fibroblast activation protein (FAP) in patients with malignant solid tumors. Based on promising preclinical studies, we have designed and synthesized a bispecific probe, B6FA-01, which can simultaneously bind to both targets. By concurrently targeting two independent, highly expressed targets-one on tumor epithelial cells (αvβ6) and one within the tumor stroma (FAP)-this probe is expected to address the issue of receptor heterogeneity that limits current single-target probes like ⁶⁸Ga-FAPI or ⁶⁸Ga-Trivehexin. Indeed, preclinical data indicate that ⁶⁸Ga-B6FA-01 exhibits not only excellent targeting affinity and specificity but also higher tumor uptake, longer intratumoral retention, faster renal clearance, and a favorable biocompatibility profile compared to its single-target counterparts.
In this prospective study, patients with histologically confirmed malignant solid tumors will undergo ⁶⁸Ga-B6FA-01 PET/CT imaging. Key PET parameters-including the maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), and tumor-to-background ratio (TBR)-will be analyzed to assess their diagnostic performance (sensitivity, specificity, accuracy). Furthermore, the study will explore the correlation between these in vivo imaging parameters and the ex vivo expression levels of αvβ6 and FAP in tumor tissues.
The findings from this study could establish αvβ6- and FAP-targeted PET imaging as a superior, non-invasive tool for tumor diagnosis and treatment assessment.
- Conditions
- PET / CT, Solid Tumors, Adult
- Being tested
- PET/CT Imaging with αvβ6/FAP-targeted tracer
- Keywords
- integrin αVβ6, FAP, PET imaging, Diagnostic efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT Imaging with αvβ6/FAP-targeted tracerDiagnostic test
Intravenous administration of αvβ6/FAP-targeted tracer (111~185 MBq), followed by whole-body PET/CT scan 30~60 minutes post-injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: PET/CT Imaging with αvβ6/FAP-targeted tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
The connection between B6FA-01 PET parameters and histopathological biomarkers.
Analyze the correlation between B6FA-01 PET parameters (SUVmax/SUVmean/SUVpeak, measured in the Syngo Workstation (Siemens Healthineers)) and FAP and αVβ6 expression levels (H-score; immunohistochemistry) or immune - related biomarkers, such as PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay), CD8 expression (H-score; immunohistochemistry).
Measured: Within 4 weeks of B6FA-01 PET scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PET / CTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong He, Zhongnan Hospital
- Investigators
- Yong He, MD, PhD, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385950
- Sponsor's protocol ID
- IIT2025383
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing plan for individual participant data (IPD) from this single-center, investigator-initiated trial has not yet been finalized. The decision will depend on several factors, including the final data governance policies of Zhongnan Hospital of Wuhan University, future intellectual property considerations, and the specific requirements of potential collaborative or publication opportunities. A formal plan will be developed in accordance with institutional guidelines and prevailing best practices for data sharing in clinical research. Data may potentially be made available upon reasonable request and subject to appropriate ethical and administrative approvals.
Publications
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.
PubMed 36276644
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Efficacy of a αvβ6/FAP-Targeting Heterodimeric Probe in Patients With Malignant Solid Tumors: An Open-Label, Single-Arm, Single-Center Study
- ClinicalTrials.gov ID
- NCT07385950
- Acronym / sponsor ID
- IIT2025383
- Conditions
- PET / CT, Solid Tumors, Adult
- Keywords
- integrin αVβ6, FAP, PET imaging, Diagnostic efficacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This investigator-initiated trial (IIT) aims to evaluate the clinical utility of positron emission tomography (PET) imaging targeting both integrin αvβ6 and fibroblast activation protein (FAP) in patients with malignant solid tumors. Based on promising preclinical studies, we have designed and synthesized a bispecific probe, B6FA-01, which can simultaneously bind to both targets. By concurrently targeting two independent, highly expressed targets-one on tumor epithelial cells (αvβ6) and one within the tumor stroma (FAP)-this probe is expected to address the issue of receptor heterogeneity that limits current single-target probes like ⁶⁸Ga-FAPI or ⁶⁸Ga-Trivehexin. Indeed, preclinical data indicate that ⁶⁸Ga-B6FA-01 exhibits not only excellent targeting affinity and specificity but also higher tumor uptake, longer intratumoral retention, faster renal clearance, and a favorable biocompatibility profile compared to its single-target counterparts.
In this prospective study, patients with histologically confirmed malignant solid tumors will undergo ⁶⁸Ga-B6FA-01 PET/CT imaging. Key PET parameters-including the maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), and tumor-to-background ratio (TBR)-will be analyzed to assess their diagnostic performance (sensitivity, specificity, accuracy). Furthermore, the study will explore the correlation between these in vivo imaging parameters and the ex vivo expression levels of αvβ6 and FAP in tumor tissues.
The findings from this study could establish αvβ6- and FAP-targeted PET imaging as a superior, non-invasive tool for tumor diagnosis and treatment assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recipients with Malignant solid tumors | – | Diagnostic Test: PET/CT Imaging with αvβ6/FAP-targeted tracerParticipants: 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT Imaging with αvβ6/FAP-targeted tracerIntravenous administration of αvβ6/FAP-targeted tracer (111~185 MBq), followed by whole-body PET/CT scan 30~60 minutes post-injection. | Diagnostic test | Recipients with Malignant solid tumors |
Primary outcome
The diagnostic sensitivity and specificity of 68Ga-B6FA-01 PET/CT in the staging of malignant tumors
Time frame: 3 years
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.
1 secondary outcome
The connection between B6FA-01 PET parameters and histopathological biomarkers.
Time frame: Within 4 weeks of B6FA-01 PET scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 36276644Zang 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.
- Individual participant dataSharing planned: Undecided. The data sharing plan for individual participant data (IPD) from this single-center, investigator-initiated trial has not yet been finalized. The decision will depend on several factors, including the final data governance policies of Zhongnan Hospital of Wuhan University, future intellectual property considerations, and the specific requirements of potential collaborative or publication opportunities. A formal plan will be developed in accordance with institutional guidelines and prevailing best practices for data sharing in clinical research. Data may potentially be made available upon reasonable request and subject to appropriate ethical and administrative approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong He, MD, PhD principal investigator
Zhongnan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PET / CT and Solid Tumors, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong He, MD, PhD (+86-27-67812698, heyong@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic sensitivity and specificity of 68Ga-B6FA-01 PET/CT in the staging of malignant tumors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.