99mTc-H7ND SPECT/CT Imaging in NSCLC

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05999214
• Collaborator: (none)
• Enrollment: 150
• Arms: 2
• Anticipated Duration (Months): 36

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
• Anticipated Study Start Date: Aug 10, 2023
• Anticipated Primary Completion Date: Aug 10, 2025
• Anticipated Study Completion Date: Aug 10, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group 99mTc-H7ND SPECT/CT imaging was performed	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.
No Intervention: Control group 99mTc-H7ND SPECT/CT imaging was not performed

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• First Affiliated Hospital Xi'an Jiaotong University

Investigators

• Study Chair: Rui Gao, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT05999214
• Other Study ID Numbers: XJTU1AF2023LSK-381
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by First Affiliated Hospital Xi'an Jiaotong University: 99mTc-H7ND; SPECT/CT; NSCLC; diagnostic efficiency; therapeutic effect evaluation

Study Results

No Results Posted as of Aug 21, 2023