Nasopharyngeal CancersNCT07890038
The Clinical Application Value of CAIX-Targeted PET Hypoxia Imaging in Malignant Tumors
An observational study of Nasopharyngeal Cancers and Lung Cancer (NSCLC), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This project involves conducting integrated PET/MR or PET/CT imaging using a CAIX-targeted PET tracer (e.g., [68Ga]Ga-DOTA-CAIX peptide) in clinically diagnosed malignant tumor patients, aiming to achieve the following objectives: Patients with malignant tumors: To visually assess the hypoxic state of malignant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancers, Lung Cancer (NSCLC), Esophageal Cancer
- What is being tested?
- Specific PET Imaging Agent Targeting CAIX
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to 30 Jun 2027
- Phase
- Observational
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected or diagnosed malignant diseases, such as lung cancer, nasopharyngeal cancer, esophageal cancer, glioma, etc. (supported by evidence including serum tumor markers, ultrasound, CT, MRI, and histopathological examinations), have an overall good condition.
All baseline subjects who meet any exclusion criteria will be excluded from the study (1) Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.); (2) Having other comorbidities; (3) Patients known to be allergic to targeted CAIX PET imaging agents or synthetic excipients; Fasting blood glucose levels exceeding 11.0 mmol/L before injection of [18F] FDG; (4) Having a history of concomitant medication; (5) Researchers believe that patients with poor compliance; (6) Pregnant or lactating patients; (7) Individuals with other factors that are not suitable for participating in this experiment.
-
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, Hubei Province, China.
Wuhan, 430000
About this study
This project involves conducting integrated PET/MR or PET/CT imaging using a CAIX-targeted PET tracer (e.g., [68Ga]Ga-DOTA-CAIX peptide) in clinically diagnosed malignant tumor patients, aiming to achieve the following objectives:
Patients with malignant tumors: To visually assess the hypoxic state of malignant tumors, with pathological immunohistochemical detection of CAIX expression levels as the gold standard, evaluate the detection efficacy and quantitative accuracy of CAIX PET imaging for tumor hypoxic regions; clarify the location, extent, and heterogeneous distribution characteristics of hypoxic subregions within tumors; conduct a head-to-head comparison with [18F]FDG PET imaging to assess the complementary value and differences of the two imaging techniques in tumor boundary delineation, metastatic lesion detection, and tumor burden evaluation; based on the hypoxic biological information provided by CAIX PET imaging, assist clinicians in designing hypoxia-conformal margin expansion for radiotherapy target volumes, aiding in the determination of personalized radiotherapy and combined treatment plans.
- Conditions
- Nasopharyngeal Cancers, Lung Cancer (NSCLC), Esophageal Cancer, Glioma
- Being tested
- Specific PET Imaging Agent Targeting CAIX
- Medical subject headings
- Nasopharyngeal Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific PET Imaging Agent Targeting CAIXDiagnostic test
This project utilizes CAIX specific targeted PET radiotracer to perform PET/CT imaging on healthy volunteers and clinically suspected or diagnosed patients with malignant tumors such as lung cancer, nasopharyngeal cancer, esophageal cancer, glioma, etc
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and standardized uptake values assessment of lesions and biodistribution
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of the tumor and organs will be measured after a semiquantitative analysis is performed for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting LRRC15 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or a higher stage.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start11 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890038
- Sponsor's protocol ID
- XLan-260608
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No