NeoplasmsNCT05593107
68Ga-N188 PET/CT Imaging in Malignancy
A study testing [68Ga]N188 in people with Neoplasms, run by Peking University First Hospital at 1 site in China.
Trial summary
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- [68Ga]N188
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteChina
- Study dates
- 12 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with confirmed or suspected cancer;
- 18F-FDG PET/CT within 1 week;
- Signed written informed consent.
Who cannot join
- Pregnant and lactating women;
- Female patients plan to become pregnant within 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jianhua Zhang, +861083572791, zjhjn820@163.com
Jianhua Zhang, Dr.
About this study
Official title: A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.
[68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
- Conditions
- Neoplasms
- Being tested
- [68Ga]N188
- Keywords
- [68Ga]N188, Nectin-4, PET/CT, Neoplasms
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]N188Drug
Also called 68Ga-N188, Nectin-4 specific PET imaging
68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]N188 | Experimental | Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. Receives: Drug: [68Ga]N188 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT
Measured: 1 year
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
Measured: 1 year
Secondary outcomes (3)
The dosimetry of 68Ga-N188
Research on the dose distribution of 68Ga-N188 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software
Measured: 1 year
Quantitative evaluation of 68Ga-N188
Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve.
Measured: 1 year
Correlation with pathological expression
Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start12 Aug 2022
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua ZHANG, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593107
- Sponsor's protocol ID
- [68Ga]N188
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang J, Duan X, Chen X, Zhang Z, Sun H, Shou J, Zhao G, Wang J, Ma Y, Yang Y, Tian X, Shen Q, Yu W, He Z, Fan Y, Yang X. Translational PET Imaging of Nectin-4 Expression in Multiple Different Cancers with 68Ga-N188. J Nucl Med. 2024 May 6;65(Suppl 1):12S-18S. doi: 10.2967/jnumed.123.266830.
PubMed 38719240
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors
- ClinicalTrials.gov ID
- NCT05593107
- Acronym / sponsor ID
- [68Ga]N188
- Conditions
- Neoplasms
- Keywords
- [68Ga]N188, Nectin-4, PET/CT, Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 203 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 25 Oct 2022 (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.
The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.
[68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]N188 | Experimental | Drug: [68Ga]N188Subjects with suspected or confirmed malignancy will receive an intravenous injection of 68Ga-N188 followed by PET imaging. The subjects will also receive a whole-body 18F-FDG PET/CT scan within a one-week period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with confirmed or suspected cancer;
- 18F-FDG PET/CT within 1 week;
- Signed written informed consent.
Key exclusion criteria (2 listed)
- Pregnant and lactating women;
- Female patients plan to become pregnant within 6 months.
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 |
|---|---|---|
| [68Ga]N188Also: 68Ga-N188, Nectin-4 specific PET imaging68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg. | Drug | [68Ga]N188 |
Primary outcome
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Time frame: 1 year
Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors
Time frame: 1 year
Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.
3 secondary outcomes
The dosimetry of 68Ga-N188
Time frame: 1 year
Quantitative evaluation of 68Ga-N188
Time frame: 1 year
Correlation with pathological expression
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
- Derived from this study: PubMed 38719240Zhang J, Duan X, Chen X, Zhang Z, Sun H, Shou J, Zhao G, Wang J, Ma Y, Yang Y, Tian X, Shen Q, Yu W, He Z, Fan Y, Yang X. Translational PET Imaging of Nectin-4 Expression in Multiple Different Cancers with 68Ga-N188. J Nucl Med. 2024 May 6;65(Suppl 1):12S-18S. doi: 10.2967/jnumed.123.266830.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]N188 in people with Neoplasms, run by Peking University First 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Zhang, Dr. (+861083572791, zjhjn820@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT05593107, 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 21 Nov 2024.