Malignant Solid TumorsCAIX-PETNCT07833085
CAIX-targeted PET/CT in Solid Tumors
A study testing 68Ga-CAIX in people with Malignant Solid Tumors and Clear Cell Renal Cell Carcinoma, run by Zhongnan Hospital at 1 site in China.
Trial summary
Tumor hypoxic microenvironment plays an important role in the initiation and progression of solid tumors, as well as tumor invasion, metastasis, and treatment resistance. Carbonic anhydrase IX (CAIX), as a crucial downstream molecule regulated by hypoxia-inducible factor-1 (HIF-1), is highly expressed in various solid… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Solid Tumors, Clear Cell Renal Cell Carcinoma, Lung Cancer (NSCLC)
- What is being tested?
- 68Ga-CAIX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2026to 31 Dec 2031
- Phase
- Interventional
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with suspected malignant solid tumors or patients with newly diagnosed or recurrent/metastatic malignant solid tumors confirmed by histopathology;
- Age of 18 years and above, both male and female are eligible;
- The ECOG PS score for physical condition in the Eastern Cancer Collaboration Group is 0-1 points;
- Research participants voluntarily sign informed consent forms or have their parents/children/legal guardians sign informed consent forms, and are able to complete the trial according to the requirements of the research protocol.
Who cannot join
- Participants with severe liver and kidney dysfunction and cardiac dysfunction;
- Participants with severe obesity, claustrophobia, or other reasons who are unable to undergo PET scans;
- Pregnant or lactating women;
- Other situations that researchers believe should be excluded and documented.
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, 1 recruiting
- Recruiting
Zhongnan hospital of Wuhan University
Wuhan, Hubei, 430071
Lei Zheng, PhD, +86-27-67812787, znyyll@126.com
About this study
Official title: Carbonic Anhydrase IX-targeted PET/CT Imaging for Detecting Solid Tumors
Tumor hypoxic microenvironment plays an important role in the initiation and progression of solid tumors, as well as tumor invasion, metastasis, and treatment resistance. Carbonic anhydrase IX (CAIX), as a crucial downstream molecule regulated by hypoxia-inducible factor-1 (HIF-1), is highly expressed in various solid tumors and is closely associated with tumor invasiveness, treatment response, and prognosis; thus, it represents an ideal target for tumor diagnosis and therapy. This study aims to explore the diagnostic value of CAIX-targeted PET/CT imaging in various solid tumors, as well as the correlation between tumor uptake and tissue CAIX expression.
Read the detailed description
A hallmark of solid tumors is their intrinsic hypoxic microenvironment, which is not only closely associated with tumor metabolic reprogramming, angiogenesis, invasion, and metastasis, but also represents a key factor contributing to resistance to radiotherapy, chemotherapy, as well as certain targeted and immunotherapeutic approaches. Therefore, achieving precise, non-invasive imaging of tumor hypoxia has become a cutting-edge and prominent focus in current cancer research. Among hypoxia-related molecules, carbonic anhydrase IX (CAIX) is the most representative target for research. As a key downstream target gene of the hypoxia-inducible factor-1 (HIF-1) pathway, CAIX expression levels are closely correlated with the hypoxic state and play an important role in regulating extracellular acidification in tumor cells as well as maintaining intracellular acid-base homeostasis; CAIX is intimately involved in the survival, proliferation, invasion, and metastasis of cancer cells. Studies have demonstrated that high CAIX expression is often associated with greater tumor invasiveness, an increased risk of metastasis, and a worse patient prognosis. Compared to other hypoxia-related molecules, CAIX expression is relatively limited in normal tissues-primarily observed in a small number of tissues such as certain gastrointestinal epithelial cells-but it exhibits abnormally high expression in various malignant tumors, including clear cell renal cell carcinoma, non-small cell lung cancer, colorectal cancer, breast cancer, and brain tumors. Therefore, CAIX is considered a highly promising diagnostic and therapeutic target for solid tumors.
CAIX-targeted molecular imaging probes can be classified into three major categories based on their molecular structure: antibody-based probes, small molecule-based probes, and peptide-based probes. Several CAIX-targeted probes (e.g., 68Ga-DPI-4452, 68Ga-NY104, and 18F-AlF-NYM005) have currently entered the clinical translation phase and demonstrated promising diagnostic potential for the detection of clear cell renal cell carcinoma; however, their clinical value in the diagnosis of other solid tumors remains unclear. Therefore, this study aims to further evaluate the diagnostic value of CAIX-targeted PET/CT imaging in various solid tumors (including renal cell carcinoma, non-small cell lung cancer, colorectal cancer, breast cancer, etc.) and to explore the correlation between tumor uptake and tissue CAIX expression, thereby providing a scientific basis for its subsequent routine clinical application.
- Conditions
- Malignant Solid Tumors, Clear Cell Renal Cell Carcinoma, Lung Cancer (NSCLC), Breast Cancer
- Being tested
- 68Ga-CAIX
- Medical subject headings
- Carcinoma, Renal Cell, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-CAIXDiagnostic test
The subjects receive a PET/CT scan 30-60 minutes after intravenous administration of 68Ga-CAIX
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-CAIX PET/CT imaging in solid tumors | Experimental | The subjects receive PET/CT examination 30-60 minutes after intravenous administration of 68Ga-CAIX Receives: Diagnostic Test: 68Ga-CAIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of diagnostic performance
To evaluate the diagnostic efficacy of ⁶⁸Ga-CAIX PET/CT imaging in detecting primary and metastatic lesions of malignant solid tumors.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Malignant Solid TumorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong He, MD, PhD, Principal investigator, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833085
- Sponsor's protocol ID
- 202608CAIX_ZN
- Acronym
- CAIX-PET
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nie P, Li B, Luo L, Hou F, Zhang N, Yang H, Huang X, Zhu Z, Ma S, Wu T, Xie J, Zhang M, Yang G, Wang Z. A prospective head-to-head comparison of 18F-NYM005 PET/CT and 18F-FDG PET/CT in diagnosing renal cell carcinoma. Eur J Nucl Med Mol Imaging. 2026 Jul;53(8):5002-5012. doi: 10.1007/s00259-026-07841-2. Epub 2026 Mar 20.
PubMed 41857358Yan X, Zheng G, Wang J, Liu M, Chen J, Xie Y, Fu C, Zhang Y, Zhu W, Huo L. [68Ga]Ga-NY104 PET/CT for the detection of clear cell renal cell carcinoma in presurgical patients with renal masses (NYCRPS): a prospective, single-centre, phase II study. Eur J Nucl Med Mol Imaging. 2026 Jul;53(9):5356-5364. doi: 10.1007/s00259-026-07896-1. Epub 2026 Apr 23. No abstract available.
PubMed 42020811Chen K, Cheng S, Shi J, Liu R, Wu Y, Zheng X, Song X, Zhang Y, Liu L, Wei Z, Wang Q, Li X, Dong Z, Liu Y, Yang H, Lan X, Qin C, Jiang D, Wang K, Zhang X. CA9-Targeted PET Imaging for Noninvasive Discrimination of Clear Cell Renal Cell Carcinoma and Associated Tumor Biological Features. Adv Sci (Weinh). 2026 Jul 20:e76622. doi: 10.1002/advs.76622. Online ahead of print.
PubMed 42473996McDonald PC, Winum JY, Supuran CT, Dedhar S. Recent developments in targeting carbonic anhydrase IX for cancer therapeutics. Oncotarget. 2012 Jan;3(1):84-97. doi: 10.18632/oncotarget.422.
PubMed 22289741Lau J, Lin KS, Benard F. Past, Present, and Future: Development of Theranostic Agents Targeting Carbonic Anhydrase IX. Theranostics. 2017 Sep 26;7(17):4322-4339. doi: 10.7150/thno.21848. eCollection 2017.
PubMed 29158829van Kuijk SJ, Yaromina A, Houben R, Niemans R, Lambin P, Dubois LJ. Prognostic Significance of Carbonic Anhydrase IX Expression in Cancer Patients: A Meta-Analysis. Front Oncol. 2016 Mar 29;6:69. doi: 10.3389/fonc.2016.00069. eCollection 2016.
PubMed 27066453Shamis SAK, Edwards J, McMillan DC. The relationship between carbonic anhydrase IX (CAIX) and patient survival in breast cancer: systematic review and meta-analysis. Diagn Pathol. 2023 Apr 15;18(1):46. doi: 10.1186/s13000-023-01325-9.
PubMed 37061698Ozensoy Guler O, Supuran CT, Capasso C. Carbonic anhydrase IX as a novel candidate in liquid biopsy. J Enzyme Inhib Med Chem. 2020 Dec;35(1):255-260. doi: 10.1080/14756366.2019.1697251.
PubMed 31790601Fu Z, Mowday AM, Smaill JB, Hermans IF, Patterson AV. Tumour Hypoxia-Mediated Immunosuppression: Mechanisms and Therapeutic Approaches to Improve Cancer Immunotherapy. Cells. 2021 Apr 24;10(5):1006. doi: 10.3390/cells10051006.
PubMed 33923305Chen Z, Han F, Du Y, Shi H, Zhou W. Hypoxic microenvironment in cancer: molecular mechanisms and therapeutic interventions. Signal Transduct Target Ther. 2023 Feb 17;8(1):70. doi: 10.1038/s41392-023-01332-8.
PubMed 36797231