MalignancyPhase 2NCT05761366
Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
A Phase 2 study testing Al18F-PSMA-BCH PET/CT in people with Malignancy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- Al18F-PSMA-BCH PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 13 Oct 2022to 13 Oct 2025
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
- Age is 18 or older; No gender limitation.
- Signed the informed consent.
- Willing and able to cooperate with all projects in this study.
Who cannot join
- Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
- Claustrophobia.
- Pregnant or lactation women.
- Received experimental drug or device within 1 month.
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
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Chaoyang, 100029
Xin Cheng, MD, 15120002998, cxpumc@foxmail.com
About this study
In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.
Read the detailed description
Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.
- Conditions
- Malignancy
- Being tested
- Al18F-PSMA-BCH PET/CT
- Keywords
- Malignancy, Prostate Specific Membrane Antigen Positive Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-PSMA-BCH PET/CTDrug
Also called 18F-Thretide PET/CT
Patients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| Al18F-PSMA-BCH PET/CT | Experimental | Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.） Receives: Drug: Al18F-PSMA-BCH PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor
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 posted9 Mar 2023
- Study start13 Oct 2022
- Primary completion13 Oct 2025 (estimated)
- Study completion13 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Zheng, MD, Principal investigator, National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761366
- Sponsor's protocol ID
- NCC3688
- Status last verified
- Dec 2024
- First submitted
- 19 Feb 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 18F-PSMA PET / CT Imaging in Prostate Specific Membrane Antigen Positive Tumor
- ClinicalTrials.gov ID
- NCT05761366
- Acronym / sponsor ID
- NCC3688
- Conditions
- Malignancy
- Keywords
- Malignancy, Prostate Specific Membrane Antigen Positive Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Oct 2025 (estimated)
- Study completion
- 13 Oct 2025 (estimated)
- First posted
- 9 Mar 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.
In this study, Al18F-PSMA-BCH PET/CT will be performed in patients with prostate specific membrane antigen positive tumor, to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.
Detailed description
Al18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors (including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.) , to evaluate the tumour detection efficacy of Al18F-PSMA-BCH PET/CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-PSMA-BCH PET/CT | Experimental | Drug: Al18F-PSMA-BCH PET/CTAl18F-PSMA-BCH PET/CT will be performed on patients with suspected or clearly diagnosed PSMA positive-expressing tumors.（including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.） |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with suspected or clearly diagnosed PSMA positive-expressing tumors, including prostate cancer, transitional epithelial carcinoma, colon carcinoma, adenoid cystadenocarcinoma, mesothelioma, hepatocellular carcinoma, cholangiocellular carcinoma, multiple myeloma, etc.
- Age is 18 or older; No gender limitation.
- Signed the informed consent.
- Willing and able to cooperate with all projects in this study.
Key exclusion criteria (4 listed)
- Patients with serious neurological diseases,or gastrointestinal tract disease, cardiovascular disease, liver disease, kidney disease, blood system disease, endocrine system disease, respiratory system disease, immune deficiency disease, etc
- Claustrophobia.
- Pregnant or lactation women.
- Received experimental drug or device within 1 month.
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 |
|---|---|---|
| Al18F-PSMA-BCH PET/CTAlso: 18F-Thretide PET/CTPatients will be intravenously injected with Al18F-PSMA-BCH and undergo PET/CT scan. | Drug | Al18F-PSMA-BCH PET/CT |
Primary outcome
Diagnostic value
Time frame: through study completion, an average of 1 year
Sensitivity and Specificity of 18F-PSMA PET / CT for the diagnosis of Prostate Specific Membrane Antigen Positive Tumor
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 27 Dec 2024.
- 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.
Rong Zheng, MD principal investigator
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Al18F-PSMA-BCH PET/CT in people with Malignancy, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 4 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: looking for participants now, as of the sponsor's last update on 27 Dec 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.
What does this phase mean?
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?
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 Xin Cheng, MD (15120002998, cxpumc@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (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 27 Dec 2024.