99mTc-H7ND SPECT/CT Imaging in NSCLC

Not Applicable

Recruiting

• Conditions: NSCLC
• Interventions: Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed

• Registration Number: NCT05999214
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

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

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-08-17
• Study First Posted: 2023-08-21
• Study Start: 2023-09-13
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25
• Primary Completion: 2025-08-10
• Study Completion: 2026-08-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	99mTc-H7ND SPECT/CT imaging performed	99mTc-H7ND SPECT/CT imaging was performed

Primary Outcome Measures

Name	Time	Method
DCR	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment	Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.

Secondary Outcome Measures

Name	Time	Method
PFS	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment	The PFS of NSCLC patients with stable disease assessed by RECIST1.1
OS	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment	The OS of NSCLC patients with stable disease assessed by RECIST1.1

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China