Clinical trial NCT05999214: 99mTc-H7ND SPECT/CT Imaging in NSCLC
Official title: 99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NSCLC
Keywords: 99mTc-H7ND
SPECT/CT
NSCLC
diagnostic efficiency
therapeutic effect evaluation
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

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.

Primary outcomes:
measure: DCR
timeFrame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Secondary outcomes:
measure: PFS
timeFrame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
measure: OS
timeFrame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Rui Gao
role: STUDY_CHAIR
References: