Medullary thyroid carcinoma (MTC), stomach cancer (especially gastric adenocarcinoma), gastroenteropancreatic neuroendocrine tumors, lung cancer (particularly small cell lung cancer)
Conditions
Interventions
Experimental group:68Ga-DOTA-M1 molecular probe
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years, any gender, willing to sign the informed consent form and able to cooperate with the examinations; 2. Tumors confirmed by histology or cytology, such as: (1) Medullary thyroid carcinoma (MTC); (2) Neuroendocrine tumors (e.g., gastrointestinal/pancreatic neuroendocrine tumors); (3) Gastric cancer or other solid tumors with literature-supported CCK-2R expression; 3. Lesions identifiable by imaging (CT/MRI/PET), with suspected metastasis or recurrence; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2; 5. Expected survival =3 months, with good kidney and liver function (ALT =150 U/L, AST =120 U/L, Cr =180 µmol/L); 6. Blood counts meeting examination requirements (white blood cells =2.5×10^9/L, platelets =60×10^9/L, hemoglobin =90 g/L); 7. Female subjects must not be pregnant or breastfeeding and willing to use effective contraception during the study; 8. No anti-tumor treatment or imaging examination that may affect target expression (e.g., radiotherapy, targeted drugs) in the 4 weeks prior to the study.
Exclusion criteria
Exclusion criteria: 1. Known allergy to probe components (such as minigastrin, DOTA, chelating agents, Ga, etc.). 2. Pregnant or breastfeeding women. 3. Presence of severe uncontrolled diseases (such as heart failure, infections, epilepsy, etc.). 4. Receiving other radiopharmaceutical treatments/contrast agent treatments without an appropriate washout period (generally 4–6 weeks). 5. Use of gastrin-related drugs (such as proton pump inhibitors) within the past 14 days that may interfere with probe binding. 6. Inability to complete a PET/CT or PET-MR scan (such as claustrophobia or inability to lie flat). 7. Mental condition not suitable to provide informed consent, or lack of independent decision-making capacity. 8. Participation in other research protocols or clinical care within the past year, resulting in radiation exposure exceeding an effective dose of 50 mSv, apart from the expected exposure from this clinical study. 9. Any other circumstances deemed by the investigator to make participation in this trial unsuitable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor diagnostic performance of 68Ga-DOTA-M1 imaging (sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV)); | — |
Countries
China
Contacts
Public ContactYi Heqing
Zhejiang Cancer Hospital
Outcome results
None listed