Primary Sjögren SyndromePhase 1/2NCT06049368
68Ga-P16-093 PET/CT Imaging in the Salivary Gland
A Phase 1/2 study testing 68Ga-P16-093 in people with Primary Sjögren Syndrome, run by Peking Union Medical College Hospital.
Trial summary
Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Sjögren Syndrome
- What is being tested?
- 68Ga-P16-093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 31 Mar 2024
- Phase
- Phase 1/2
- 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
- pathological diagnosis confirmed by operation or biopsy.
- Obtain written informed consent and accepted follow-up.
Who cannot join
- Pregnant, lactating women or having parenting plans during the study
- Head and neck radiotherapy history ;
- Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.
- Other situaition researchers considered it was not appropriate to participate in trials.
Trial locations and contacts
No sites are listed yet.
About this study
Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.
Read the detailed description
Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.
- Conditions
- Primary Sjögren Syndrome
- Being tested
- 68Ga-P16-093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-P16-093Drug
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-P16-093 | Experimental | Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093. Receives: Drug: 68Ga-P16-093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance
evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
standardized uptake value (SUV) of lesion
comparing the SUVmax of different grades in salivary gland lesion, derived from 68Ga-P16-093
Measured: through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049368
- Sponsor's protocol ID
- PUMCH-PSS093
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-P16-093 PET/CT Imaging in the Salivary Gland
- ClinicalTrials.gov ID
- NCT06049368
- Acronym / sponsor ID
- PUMCH-PSS093
- Conditions
- Primary Sjögren Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 22 Sep 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.
Prostate specific membrane antigen (PSMA) is a type II transmembrane protein and acts as a glutamate carboxypeptidase enzyme. It is first described in prostate cancer cell lines and later identified in various tissues, include salivary gland. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in primary sjogren's syndrome patients.
Detailed description
Primary sjogren's syndrome (pSS) is a systemic autoimmune disease mainly presented hyperglobulinemia and exocrine gland involvement,and lack of diagnostic gold standard.Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by various solid organs , such as salivary gland,which is often observed damage in primary Sjogren's syndrome patients.Therefore, PSMA may be an ideal target for evaluating salivary gland injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-P16-093 | Experimental | Drug: 68Ga-P16-093Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pathological diagnosis confirmed by operation or biopsy.
- Obtain written informed consent and accepted follow-up.
Key exclusion criteria (4 listed)
- Pregnant, lactating women or having parenting plans during the study
- Head and neck radiotherapy history ;
- Active hepatitis C infection (PCR positive), include immunodeficiency syndrome, sarcoidosis, amyloidosis, graft versus host disease, IgG4 related diseases.
- Other situaition researchers considered it was not appropriate to participate in trials.
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-P16-093Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT. | Drug | 68Ga-P16-093 |
Primary outcome
Diagnostic performance
Time frame: through study completion, an average of 1 year
evaluating the number of regions in damaged salivary glands detected by 68Ga-P16-093
1 secondary outcome
standardized uptake value (SUV) of lesion
Time frame: through study completion, an average of 1 year]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
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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.
Zhaohui Zhu, MD principal investigator
Peking Union Medical College Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-P16-093 in people with Primary Sjögren Syndrome, run by Peking Union Medical College Hospital.
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 2 inclusion and 4 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhaohui Zhu, MD (86-13611093752, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance (time frame: through study completion, an average of 1 year). 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 22 Sep 2023.