NSCLCNCT05999214
99mTc-H7ND SPECT/CT Imaging in NSCLC
A study testing 99mTc-H7ND SPECT/CT imaging performed in people with NSCLC, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- 99mTc-H7ND SPECT/CT imaging performed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 13 Sep 2023to 10 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Rui Gao, 0086-13772488039, jacky_mg@xjtufh.edu.cn
Xinru Li, 0086-15991432495, lixinru@xjtu.edu.cn
About this study
Official title: 99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
To study the clinical application of 99mTc-H7ND SPECT/CT imaging in the efficacy evaluation and prediction of non-small cell lung cancer (NSCLC)
Read the 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
- Being tested
- 99mTc-H7ND SPECT/CT imaging performed
- Keywords
- 99mTc-H7ND, SPECT/CT, NSCLC, diagnostic efficiency, therapeutic effect evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-H7ND SPECT/CT imaging performedDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 99mTc-H7ND SPECT/CT imaging was performed Receives: Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed |
| Control group | No intervention | 99mTc-H7ND SPECT/CT imaging was not performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
DCR
Comparison of DCR in groups of NSCLC patients with stable disease assessed by RECIST1.1.
Measured: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Secondary outcomes (2)
PFS
The PFS of NSCLC patients with stable disease assessed by RECIST1.1
Measured: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
OS
The OS of NSCLC patients with stable disease assessed by RECIST1.1
Measured: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Sep 2023
- Primary completion10 Aug 2025 (estimated)
- Study completion10 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Gao, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999214
- Sponsor's protocol ID
- XJTU1AF2023LSK-381
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTc-H7ND SPECT/CT Imaging in Non-small Cell Lung Cancer Clinical Application Research in Efficacy Evaluation and Efficacy Prediction
- ClinicalTrials.gov ID
- NCT05999214
- Acronym / sponsor ID
- XJTU1AF2023LSK-381
- Conditions
- NSCLC
- Keywords
- 99mTc-H7ND, SPECT/CT, NSCLC, diagnostic efficiency, therapeutic effect evaluation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 10 Aug 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: 99mTc-H7ND SPECT/CT imaging performed99mTc-H7ND SPECT/CT imaging was performed |
| Control group | No intervention | –99mTc-H7ND SPECT/CT imaging was not performed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-H7ND SPECT/CT imaging performed99mTc-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. | Diagnostic test | Experimental group |
Primary outcome
DCR
Time frame: 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.
2 secondary outcomes
PFS
Time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
OS
Time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rui Gao study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-H7ND SPECT/CT imaging performed in people with NSCLC, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rui Gao (0086-13772488039, jacky_mg@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DCR (time frame: Repeat visits were performed 8-12 weeks and 12 weeks after the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.