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Breast Neoplasms、Lung Neoplasms、Pancreatic NeoplasmsNCT07331532

68Ga-PFA2 PET Imaging for the Diagnosis of Annexin A2-Positive Tumors

An observational study of Breast Neoplasms、Lung Neoplasms、Pancreatic Neoplasms, run by Peking University First Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Tumor metastasis and invasion are the leading causes of cancer-related deaths, with over 90% of cancer patients dying from distant metastasis. Tumor cells spread to distant organs through local infiltration, hematogenous metastasis, or lymph node metastasis, complicating treatment and severely affecting the prognosis… Read more about this study

Who is it for?
Ages 18 to 80 years
How many people
10 participants
Where
1 siteChina
Study dates
1 Jun 2025to 1 Oct 2027
How long will I take part?
12 Months
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study will include lung cancer patients, both suspected and confirmed, who are scheduled to undergo PET/CT imaging using the 68Ga-PFA2 probe. The study will focus on patients aged 18-80 years with confirmed lung cancer, and the participants should be able to understand the study protocol, provide informed consent, and cooperate with examination procedures.

Who may be able to join

  • Patients aged 18-80 years.
  • Diagnosed with confirmed lung cancer.
  • Scheduled to undergo pathological tissue biopsy or surgical treatment within the next two months.
  • Able to fully comprehend and voluntarily participate in the study.
  • Able to provide informed consent.
  • Capable of cooperating independently to complete the examinations.

Who cannot join

  • Patients with other malignancies or severe comorbidities that affect their ability to participate.
  • Patients unable to provide informed consent due to cognitive impairment.
  • Patients with contraindications to PET/CT scans or 68Ga-PFA2 administration.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tingting Yuan contact

+86-13051707479

biluohtt@163.com

China1 site, 1 recruiting
  • Peking university first hospital nuclear medicine

    Beijing, Beijing Municipality

    Tingting Yuan, +86-13051707479, biluohtt@163.com

    Tingting Yuan

    Recruiting

Other trials in China

About this study

Official title: PET Imaging Study of 68Ga-PFA2 Probe for Annexin A2-Positive Tumors

Tumor metastasis and invasion are the leading causes of cancer-related deaths, with over 90% of cancer patients dying from distant metastasis. Tumor cells spread to distant organs through local infiltration, hematogenous metastasis, or lymph node metastasis, complicating treatment and severely affecting the prognosis and survival rate of patients. Therefore, precise and early assessment of tumor invasion and metastasis is crucial for optimizing personalized treatment plans and improving patient survival.

Currently, the detection of tumor metastasis primarily relies on imaging examinations, blood biomarkers, and histopathological analysis. Among these, 18F-FDG PET/CT plays a key role in tumor staging and distant metastasis evaluation. However, its sensitivity is low for certain tumors, such as well-differentiated hepatocellular carcinoma, colorectal cancer, and glioblastoma, and factors like inflammation can lead to false positives. Additionally, serum tumor markers (such as AFP, CEA, and CA19-9) often lack specificity in some patients, and histopathological analysis requires invasive sampling, making real-time monitoring difficult. Therefore, the development of non-invasive methods based on molecular targets for early and precise detection of tumor invasion and metastasis holds significant clinical value.

Read more

Tumor invasion and metastasis is a complex process involving multiple molecules that drive cancer cell proliferation, invasion of surrounding tissues, and the formation of secondary tumors in distant organs. During invasion and metastasis, cancer cells are often subjected to mechanical stress, such as compression and shear forces, making the repair of cell membrane damage crucial for the survival of invasive cancer cells. Annexin A2 (ANXA2) is a multifunctional protein that plays a key role in cancer cell membrane repair, proliferation, migration, invasion, and metastasis. Studies have shown that silencing ANXA2 or inhibiting its function with neutralizing antibodies reduces the ability of cancer cells to repair membrane damage, thereby limiting tumor cell dissemination. Abnormal expression of ANXA2 is a common feature in many types of tumors. The expression level of ANXA2 in tumors is closely associated with the growth, invasion, and metastasis of pancreatic cancer, colorectal cancer, breast cancer, gliomas, and other tumors.

Furthermore, ANXA2 promotes tumor cell proliferation by facilitating DNA replication, cell cycle progression, and neovascularization, thereby supporting tumor growth and progression. For instance, in breast cancer, ANXA2 promotes STAT3 activation through Tyr23 phosphorylation, upregulating cyclin D1 and MMP2/9, which accelerates breast cancer proliferation, invasion, and metastasis. In pancreatic cancer, ANXA2 regulates the Src/ANXA2/STAT3 signaling pathway to promote epithelial-mesenchymal transition (EMT), enhancing cellular invasiveness. In non-small cell lung cancer (NSCLC), ANXA2 overexpression correlates with tumor staging, lymph node metastasis, and distant metastasis, and can serve as an independent prognostic marker. In hepatocellular carcinoma (HCC), high ANXA2 expression is not only associated with higher tumor recurrence rates but also promotes angiogenesis, further driving tumor progression. In glioblastoma (GBM) and colorectal cancer, ANXA2 has also been shown to accelerate disease progression through mechanisms such as extracellular matrix degradation, angiogenesis, and tumor microenvironment regulation.

ANXA2 not only serves as a poor prognostic factor for various cancers but also holds potential as a therapeutic target. Several monoclonal antibodies targeting ANXA2 have shown significant antitumor and antiangiogenic effects. Rajkumar et al. demonstrated that the monoclonal antibody mAb150, targeting the N-terminal epitope of ANXA2, enhances cancer stem cells' re-entry into the cell cycle, reducing migration and EMT in activated cancer cells, ultimately inhibiting ascites formation and extending survival in a mouse ovarian cancer model. Another monoclonal antibody, ch2448, targets the unique glycan epitope of ANXA2, triggering antibody-dependent cell-mediated cytotoxicity, effectively inhibiting tumor formation and delaying or preventing teratoma development. In addition to large molecular antibodies, the first small-molecule inhibitor of ANXA2 in triple-negative breast cancer, 5α-epoxyalantolactone (5-EAL), has been discovered. 5-EAL selectively binds to the conserved cysteine residue of ANXA2, inhibiting the formation of the ANXA2-S100A10 heterotetramer complex, effectively suppressing TNBC proliferation and metastasis. These findings highlight the enormous diagnostic and therapeutic potential of ANXA2 as a biomarker for malignant cancers.

Given the high expression of ANXA2 in various tumors and

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07331532
Study groupRoleWhat they receive
Lung cancer patients will undergo PET/CT imaging with 68Ga-PFA2 to assess metastasis detection.Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic Performance of 68Ga-PFA2 PET Imaging in Detecting Metastasis in Lung Cancer

    Measured: Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.

  2. Diagnostic Performance of 68Ga-PFA2 PET Imaging in Detecting Metastasis in Lung Cancer

    This outcome measure evaluates the ability of the 68Ga-PFA2 PET imaging probe to detect metastases in lung cancer patients, focusing on Annexin A2-positive tumors. The primary objective is to assess its diagnostic performance compared to the standard 18F-FDG PET/CT imaging.

    Measured: Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start1 Jun 2025
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
10 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07331532
Sponsor's protocol ID
PFA2 001
Status last verified
Dec 2025
First submitted
29 Dec 2025
Last updated
20 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang Y, Jia M, Yang X, Han H, Hou G, Bi L, Yang Y, Zhang R, Zhao X, Peng C, Ouyang X. Annexin A2: The diversity of pathological effects in tumorigenesis and immune response. Int J Cancer. 2022 Aug 15;151(4):497-509. doi: 10.1002/ijc.34048. Epub 2022 May 6.

    PubMed 35474212
  • Wang YQ, Zhang F, Tian R, Ji W, Zhou Y, Sun XM, Liu Y, Wang ZY, Niu RF. Tyrosine 23 Phosphorylation of Annexin A2 Promotes Proliferation, Invasion, and Stat3 Phosphorylation in the Nucleus of Human Breast Cancer SK-BR-3 Cells. Cancer Biol Med. 2012 Dec;9(4):248-53. doi: 10.7497/j.issn.2095-3941.2012.04.005.

    PubMed 23691485
  • Foley K, Rucki AA, Xiao Q, Zhou D, Leubner A, Mo G, Kleponis J, Wu AA, Sharma R, Jiang Q, Anders RA, Iacobuzio-Donahue CA, Hajjar KA, Maitra A, Jaffee EM, Zheng L. Semaphorin 3D autocrine signaling mediates the metastatic role of annexin A2 in pancreatic cancer. Sci Signal. 2015 Aug 4;8(388):ra77. doi: 10.1126/scisignal.aaa5823.

    PubMed 26243191
  • Wirtz D, Konstantopoulos K, Searson PC. The physics of cancer: the role of physical interactions and mechanical forces in metastasis. Nat Rev Cancer. 2011 Jun 24;11(7):512-22. doi: 10.1038/nrc3080.

    PubMed 21701513
  • Cleary AS, Leonard TL, Gestl SA, Gunther EJ. Tumour cell heterogeneity maintained by cooperating subclones in Wnt-driven mammary cancers. Nature. 2014 Apr 3;508(7494):113-7. doi: 10.1038/nature13187.

    PubMed 24695311
  • Chen L, Qin G, Liu Y, Li M, Li Y, Guo LZ, Du L, Zheng W, Wu PC, Chuang YH, Wang X, Wang TD, Ho JA, Liu TM. Label-free optical metabolic imaging of adipose tissues for prediabetes diagnosis. Theranostics. 2023 Jun 19;13(11):3550-3567. doi: 10.7150/thno.82697. eCollection 2023.

    PubMed 37441598
  • Ma L, Yu H, Zhu Y, Xu K, Zhao A, Ding L, Gao H, Zhang M. Isolation and proteomic profiling of urinary exosomes from patients with colorectal cancer. Proteome Sci. 2023 Feb 9;21(1):3. doi: 10.1186/s12953-023-00203-y.

    PubMed 36759883
  • Orsaria P, Chiaravalloti A, Fiorentini A, Pistolese C, Vanni G, Granai AV, Varvaras D, Danieli R, Schillaci O, Petrella G, Buonomo OC. PET Probe-Guided Surgery in Patients with Breast Cancer: Proposal for a Methodological Approach. In Vivo. 2017 Jan 2;31(1):101-110. doi: 10.21873/invivo.11031.

    PubMed 28064227
  • Ganesh K, Massague J. Targeting metastatic cancer. Nat Med. 2021 Jan;27(1):34-44. doi: 10.1038/s41591-020-01195-4. Epub 2021 Jan 13.

    PubMed 33442008

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Neoplasms、Lung Neoplasms、Pancreatic Neoplasms, run by Peking University First 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 3 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: looking for participants now, as of the sponsor's last update on 20 Jan 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 Tingting Yuan (+86-13051707479, biluohtt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic Performance of 68Ga-PFA2 PET Imaging in Detecting Metastasis in Lung Cancer (time frame: Primary data collection will be completed at the end of the study, with imaging performed at baseline and 30-minute, 60-minute intervals post-injection.). The study lists 2 primary outcomes in all. 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 NCT07331532, which also lists 9 linked publications.

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 20 Jan 2026.

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