99mTc-H7ND SPECT/CT Imaging in NSCLC

NCT ID: NCT05999214

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2026-08-10

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

Conditions

NSCLC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental group

99mTc-H7ND SPECT/CT imaging was performed

Group Type: EXPERIMENTAL

99mTc-H7ND SPECT/CT imaging performed

Intervention Type: DIAGNOSTIC_TEST

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.

Control group

99mTc-H7ND SPECT/CT imaging was not performed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Gao

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Gao

Role: CONTACT

jacky_mg@xjtufh.edu.cn

0086-13772488039

Xinru Li

Role: CONTACT

lixinru@xjtu.edu.cn

0086-15991432495

Facility Contacts

Rui Gao

Role: primary

jacky_mg@xjtufh.edu.cn

0086-13772488039

Xinru Li

Role: backup

lixinru@xjtu.edu.cn

0086-15991432495

Other Identifiers

XJTU1AF2023LSK-381

Identifier Type: -

Identifier Source: org_study_id