99mTc-H7ND SPECT/CT Imaging in NSCLC

NCT05999214 | Recruiting DMC

• 1 other identifier: XJTU1AF2023LSK-381
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

NSCLC

Keywords

99mTc-H7ND; SPECT/CT; NSCLC; diagnostic efficiency; therapeutic effect evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PFS

  Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment

• OS

  Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment

Study Arms (2)

Experimental group

EXPERIMENTAL

99mTc-H7ND SPECT/CT imaging was performed

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

Control group

NO INTERVENTION

99mTc-H7ND SPECT/CT imaging was not performed

Interventions

99mTc-H7ND SPECT/CT imaging performed 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.

Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged from 18 to 80 years old;
• 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;
• 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;
• Patients had at least one measurable lesion;
• No local radiotherapy for primary or metastatic lesions within 28 days;
• ECOG score 0-2;
• Expected survival time ≥3 months;
• Voluntarily participate and sign informed consent.

You may not qualify if:

• Women who plan to become pregnant within 6 months, or are pregnant or lactating.
• Patients with severe brain or bone metastases;
• Severe anemia and severe liver and kidney damage;
• Pathological or long-term follow-up results may not be available;
• The relevant control imaging data and clinical data were not available;
• Severe illness is difficult to cooperate (such as acute cardiovascular and cerebrovascular events or serious cardiovascular diseases);
• Received any surgery or invasive treatment or procedure within 4 weeks before enrollment;
• Cannot tolerate standard second-line therapy or other first-line therapies.
• Known allergy to 99mTc-H7ND or any of its components; He had a history of severe allergies;
• Protocol imaging contraindications were present;
• The investigator considered it inappropriate to participate in the study.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Study Officials

• Rui Gao

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Rui Gao

CONTACT

0086-13772488039; jacky_mg@xjtufh.edu.cn

Xinru Li

CONTACT

0086-15991432495; lixinru@xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 21, 2023
• Study Start: September 13, 2023
• Primary Completion: August 10, 2025
• Study Completion (Estimated): August 10, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)