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Trial Title:
99mTc-H7ND SPECT/CT Imaging in NSCLC
NCT ID:
NCT05999214
Condition:
NSCLC
Conditions: Keywords:
99mTc-H7ND
SPECT/CT
NSCLC
diagnostic efficiency
therapeutic effect evaluation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
99mTc-H7ND SPECT/CT imaging performed
Description:
99mTc-H7ND SPECT/CT imaging positive (+) was defined as the presence of at least one
measurable lesion and the uptake of the lesion was greater than that of normal liver in
the experimental group, and patients were divided into SD+ and SD-. According to the
guidelines and routine clinical practice, SD- patients were treated with the original
regimen or maintenance treatment, and SD+ patients were divided into continuation of the
original regimen or second-line treatment according to the MDT discussion results.
Arm group label:
Experimental group
Summary:
To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy
evaluation and prediction of non-small cell lung cancer (NSCLC)
Detailed description:
This study was a prospective, controlled, single-center clinical study.
To evaluate the value of 99mTc-H7ND imaging in the evaluation of stable disease in
patients with non-small cell lung cancer (NSCLC) assessed by RECIST1.1, and to predict
the efficacy of subsequent treatment (second-line treatment).
Patients with NSCLC confirmed by cytology or pathology, who were unable to undergo
radical surgery because of recurrence, metastasis, or their own conditions, and who had
completed 2-4 cycles of first-line therapy and had RECIST1.1 assessment (SD) were divided
into 2 groups:
Experimental group: 99mTc-H7ND SPECT/CT imaging performed Control group: 99mTc-H7ND
SPECT/CT imaging was not performed
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Gao
Phone:
0086-13772488039
Email:
jacky_mg@xjtufh.edu.cn
Contact backup:
Last name:
Xinru Li
Phone:
0086-15991432495
Email:
lixinru@xjtu.edu.cn
Start date:
September 13, 2023
Completion date:
August 10, 2026
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999214
