An interventional study of 68Ga-CAIX in Malignant Solid Tumors, Clear Cell Renal Cell Carcinoma and Lung Cancer (NSCLC), sponsored by Zhongnan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Zhongnan Hospital · Not applicable, Interventional, and Diagnostic
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.
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.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 100 is above the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Zhongnan Hospital is the lead sponsor of 106 studies on the registry; 49 are open to participants now.
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Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subjects receive PET/CT examination 30-60 minutes after intravenous administration of 68Ga-CAIX
Diagnostic Test: 68Ga-CAIX
The subjects receive a PET/CT scan 30-60 minutes after intravenous administration of 68Ga-CAIX
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.
Time frame: up to 6 months
Plan to share: No
Start is estimated for Sep 2026; primary completion for Dec 2030, 51 months later.
Of 119 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 114. This study's planned 51 months is close to that.
Counting every sponsor, half of 126 studies reached it within 45 months; a quarter within 22 and three quarters within 114.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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