99mTc-H7ND SPECT/CT Imaging in NSCLC

Xi'an Jiaotong University

Status: Enrolling

Conditions: NSCLC

Treatments: Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed

Study type: Interventional

Funder types: Other

Identifiers

NCT05999214

XJTU1AF2023LSK-381

Details and patient eligibility

About

To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation and prediction of non-small cell lung cancer (NSCLC)

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Experimental group

Experimental group

Description:

99mTc-H7ND SPECT/CT imaging was performed

Treatment:

Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed

Control group

No Intervention group

Description:

99mTc-H7ND SPECT/CT imaging was not performed