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Non-small Cell Lung CancerNCT06165874

[68Ga]Ga-NOTA-RW102 PET Imaging in the Diagnosis of PD-L1-expressing Lung Cancer

A study testing [68Ga]Ga-NOTA-RW102 PET Imaging in people with Non-small Cell Lung Cancer, run by Huashan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RW102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
[68Ga]Ga-NOTA-RW102 PET Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
12 Mar 2023to 14 Jan 2024
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with PD-L1-positive non-small cell lung cancer
  • Age between 18 and 65 years old, gender is not limited.
  • Patients with CT findings that can be occupied on the lung with a diameter greater than 1cm or more who have not undergone surgery.
  • Lung cancer patients with a clinical diagnosis of positive PD-L1 expression;
  • Written informed consent must be signed by the subject or his/her legal guardian or caregiver.
  • Willingness and ability to cooperate with all programs of this study.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Severe hepatic and renal insufficiency;
  • Targeted therapy prior to radiotherapy or PET/CT scan. PD-L1 expression in existing lesions was assessed by immunohistochemistry using antibody clone 22C3. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
  • Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
  • History of serious surgery in the last month.
  • Those who have participated in other clinical trials during the same period.

Trial locations and contacts

1 site in 1 country.

Yihui Guan, MD contact

+8613764308300

guanyihui@hotmail.com

China1 site, 1 recruiting

  • Huashan Hospital

    Shanghai, 200040

    Yihui Guan, MD, +8613764308300, guanyihui@hotmail.com

    Recruiting

Other trials in China

About this study

The aim of this study was to establish and optimize the imaging method of [68Ga]Ga-NOTA-RW102, as well as its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent was evaluated in patients with non-small cell lung cancer

Being tested
[68Ga]Ga-NOTA-RW102 PET Imaging
Keywords
non-small cell lung cancer, Positron-Emission Tomography
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-NOTA-RW102 PET ImagingRadiation

    Intravenous injection of 1.8 MBq[0.05MCi]/kg of [68Ga]Ga-NOTA-RW102 in a single dose.

Study groups in NCT06165874
Study groupRoleWhat they receive
non-small cell lung cancerExperimentalPatients were recruited in the Department of Thoracic Surgery
Receives: Radiation: [68Ga]Ga-NOTA-RW102 PET Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calculation and comparison of [68Ga]Ga-NOTA-RW102 radioactivity concentrations in focal and non-focal tissues

    Assessment of the efficacy of [68Ga]Ga-NOTA-RW102 in the diagnosis and differential diagnosis of non-small cell lung cancer

    Measured: 90mins from time of injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2023
  2. Study start12 Mar 2023
  3. Primary completion13 Oct 2023
  4. Study completion14 Jan 2024 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165874
Sponsor's protocol ID
KY2023-546
Status last verified
Dec 2023
First submitted
19 Nov 2023
Last updated
12 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang Y, Cao M, Wu Y, Malih S, Xu D, Yang E, Younis MH, Lin W, Zhao H, Wang C, Liu Q, Engle JW, Rasaee MJ, Guan Y, Huang G, Liu J, Cai W, Xie F, Wei W. Preclinical development of novel PD-L1 tracers and first-in-human study of [68Ga]Ga-NOTA-RW102 in patients with lung cancers. J Immunother Cancer. 2024 Apr 5;12(4):e008794. doi: 10.1136/jitc-2024-008794.

    PubMed 38580333

Questions about this trial

What is this clinical trial studying?

A study testing [68Ga]Ga-NOTA-RW102 PET Imaging in people with Non-small Cell Lung Cancer, run by Huashan Hospital 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 6 inclusion and 6 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 12 Dec 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 Yihui Guan, MD (+8613764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calculation and comparison of [68Ga]Ga-NOTA-RW102 radioactivity concentrations in focal and non-focal tissues (time frame: 90mins from time of injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06165874, which also lists 1 linked publication.

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 12 Dec 2023.

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