Imaging technique for evaluating non-small cell lung cancer treatment effectiveness
99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
This study is testing a new imaging technique to see if it can help doctors figure out how well treatments are working for patients with non-small cell lung cancer who have stable disease after their initial therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05999214 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of 99mTc-H7ND SPECT/CT imaging to assess the efficacy of treatment in patients with non-small cell lung cancer (NSCLC) who have stable disease after initial therapy. The study is a prospective, controlled, single-center trial where patients are divided into two groups: one receiving the imaging intervention and the other not. The goal is to determine how well this imaging technique can predict the effectiveness of subsequent treatments for NSCLC. Patients must have completed 2-4 cycles of first-line therapy and have measurable lesions to qualify for the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with confirmed NSCLC who cannot undergo radical surgery and have stable disease after initial treatment.
Not a fit: Patients with severe brain or bone metastases, or those with significant comorbidities that prevent participation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this imaging technique could provide a more accurate method for evaluating treatment effectiveness in NSCLC patients, potentially leading to better treatment decisions.
How similar studies have performed: While the specific use of 99mTc-H7ND SPECT/CT imaging is novel, similar imaging techniques have shown promise in evaluating treatment efficacy in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged from 18 to 80 years old; 2. patients with NSCLC confirmed by needle aspiration cytology or surgical pathology, who cannot undergo radical surgery due to recurrence, metastasis or patient's own conditions; 3. Has completed 2-4 cycles of first-line therapy (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, chemotherapy combined with targeted therapy, etc.), and has SD assessed by RECIST 1.1 during the same period; 4. Patients had at least one measurable lesion; 5. No local radiotherapy for primary or metastatic lesions within 28 days; 6. ECOG score 0-2; 7. Expected survival time ≥3 months; 8. Voluntarily participate and sign informed consent. Exclusion Criteria: 1. Women who plan to become pregnant within 6 months, or are pregnant or lactating. 2. Patients with severe brain or bone metastases; 3. Severe anemia and severe liver and kidney damage; 4. Pathological or long-term follow-up results may not be available; 5. The relevant control imaging data and clinical data were not available; 6. Severe illness is difficult to cooperate (such as acute cardiovascular and cerebrovascular events or serious cardiovascular diseases); 7. Received any surgery or invasive treatment or procedure within 4 weeks before enrollment; 8. Cannot tolerate standard second-line therapy or other first-line therapies. 9. Known allergy to 99mTc-H7ND or any of its components; He had a history of severe allergies; 10. Protocol imaging contraindications were present; 11. The investigator considered it inappropriate to participate in the study.
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Rui Gao
- Email: jacky_mg@xjtufh.edu.cn
- Phone: 0086-13772488039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.