New radioactive tracer could sharpen cancer scans
NCT ID NCT05989997
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested a new radioactive imaging agent called 68Ga-NOTA-SNA002 in 17 adults with solid tumors. The agent was injected into a vein, and researchers checked its safety, how it spreads in the body, and how well it shows up on PET scans. The goal was to see if this tracer could help doctors better see and understand tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 68Ga-NOTA-SNA002 (a radioactive imaging agent injected into a vein for PET scans)
- What this could lead to
- If successful, this could lead to a new way to see tumors on PET scans, helping doctors diagnose and monitor cancer more accurately.
- What could go wrong
- This is a very early, small Phase 1 trial focused on safety and imaging, not treatment. It may not lead to a widely used diagnostic tool, and the agent could cause side effects or unclear images.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
17 people
The number who actually took part.
- Started
-
Nov 2023
- Finished
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Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years old (including boundary values); 2. Those who have behavioral capacity, voluntarily participate in this clinical study, and sign an informed consent form (ICF); 3. Physical condition (ECOG) score 0-2 points; 4. Basal heart rate 60\~100 beats/min (including the boundary value, which refers to the seated heart rate of the patient in a calm state); 5. Blood pressure measurements \< High blood pressure level 1 (includes a history of high blood pressure, systolic blood pressure treated with exercise or medication; 140 and diastolic blood pressure\< 90mmHg); Specialty situation 6. Patients with confirmed solid tumors (including but not limited to non-small cell lung cancer, breast cancer, head and neck squamous cell carcinoma, malignant melanoma) with or without metastatic tumors; 7. Patients whose imaging findings indicate that at least one target lesion is measurable and can be biopsied (CT, MRI, or 18F-FDG PET-CT results are acceptable); 8. Pathological findings were obtained within the previous 1 year. Exclusion Criteria: 1. Patients who are unable to perform visits or undergo relevant examinations, operations or biopsies in accordance with the clinical trial protocol; 2. Poor nutritional status, screening BMI\< 18.5, can not tolerate the test; 3. People with known or suspected evidence of active autoimmune disease (e.g., vitiligo, diabetes, residual hypothyroidism due to autoimmune disease requiring hormone replacement therapy only, autoimmunological disease such as psoriasis that does not require systemic treatment), Or diseases that are not expected to recur in the absence of external triggers are allowed to be included in the study); 4. Patients who take large doses of hormones, such as hydrocortisone or 5mg prednisone in the morning and hydrocortisone or 2.5mg prednisone in the evening; 5. Patients with serious diseases or other malignant tumors (except those who have been cured one year ago or do not require additional treatment); 6. People with known severe allergy to 68Ga-NOTA-SNA002, similar drugs or excipients.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhongshan Hospital Affiliated to Fudan University
Shanghai, China
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