Actively Recruiting
99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2023-09-25
150
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of 99mTc-H7ND SPECT/CT imaging to evaluate the effectiveness and predict the outcomes of treatment in patients with non-small cell lung cancer (NSCLC). This prospective, controlled study involves patients who have NSCLC confirmed by cytology or pathology, cannot undergo radical surgery due to recurrence, metastasis, or other health reasons, and have completed 2 to 4 cycles of first-line therapy with stable disease as assessed by RECIST 1.1 criteria. Participants are divided into two groups: one undergoes the 99mTc-H7ND SPECT/CT imaging while the other does not. The imaging group is further categorized based on whether measurable lesions show uptake higher than normal liver tissue, guiding decisions on whether to continue current treatment or move to second-line therapy. The study monitors patients through repeat visits at 8-12 weeks and 12 weeks after the initial assessment. During the study, participants will undergo clinical evaluations including imaging tests and follow-up visits to assess disease control rate, progression-free survival, and overall survival. Researchers will review the imaging and clinical data collected during these visits to determine the value of 99mTc-H7ND imaging in managing NSCLC treatment. The total study duration extends until August 2026, with ongoing monitoring and assessments scheduled throughout.
CONDITIONS
Brief Title
99mTc-H7ND SPECT/CT Imaging in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged from 18 to 80 years old
- Diagnosis of non-small cell lung cancer confirmed by needle aspiration cytology or surgical pathology
- Unable to undergo radical surgery due to recurrence, metastasis, or patient conditions
- Completed 2 to 4 cycles of first-line therapy with stable disease assessed by RECIST 1.1
- At least one measurable lesion present
- No local radiotherapy for primary or metastatic lesions within 28 days
- ECOG performance status score of 0 to 2
- Expected survival time of at least 3 months
- Voluntary participation with signed informed consent
You will not qualify if you...
- Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months
- Severe brain or bone metastases
- Severe anemia or severe liver and kidney damage
- Lack of pathological or long-term follow-up data
- Missing required imaging or clinical data
- Severe illnesses that impair cooperation, such as acute cardiovascular or cerebrovascular events
- Surgery or invasive treatments within 4 weeks before enrollment
- Inability to tolerate standard second-line or first-line therapies
- Known allergy to 99mTc-H7ND or its components or history of severe allergies
- Contraindications to protocol imaging
- Investigator judgment deeming participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Baseline assessment
Participants undergo 99mTc-H7ND SPECT/CT imaging to evaluate stable disease status and predict treatment efficacy.
1 imaging visit (in-person)
Duration - Up to 12 weeks after baseline
Participants are monitored with repeat visits to assess disease control, progression-free survival, and overall survival after baseline assessment.
2 follow-up visits at 8-12 weeks and 12 weeks after baseline
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
Research Team
R
Rui Gao
X
Xinru Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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