99mTc-H7ND SPECT/CT Imaging in NSCLC

NSCLC Clinical Trial

Official title:

99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999214
• Other study ID #: XJTU1AF2023LSK-381
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2023
• Est. completion date: August 10, 2026

Study information

• Verified date: July 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Rui Gao
• Phone: 0086-13772488039
• Email: jacky_mg[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 10, 2026
• Est. primary completion date: August 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCR	Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Secondary	PFS	The PFS of NSCLC patients with stable disease assessed by RECIST1.1	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Secondary	OS	The OS of NSCLC patients with stable disease assessed by RECIST1.1	Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment