PET CTPSMANCT07162779
Evaluation of [68Ga]DOTA-IR-780-C-4 in PET Imaging Studies for PSMA-Positive Prostate Cancer Patients
A study testing Radioactive drugs are administered through intravenous injection. in people with PET CT, run by Affiliated Hospital of Jiangnan University at 1 site in China.
Trial summary
Prostate cancer is one of the most common malignant tumors in the urinary and male reproductive systems. According to the 2020 edition of the Global Cancer Statistics Report published by the WHO International Agency for Research on Cancer in February 2021, newly diagnosed prostate cancer cases worldwide accounted for… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- PET CT
- What is being tested?
- Radioactive drugs are administered through intravenous injection.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 16 Dec 2026
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and voluntarily sign the written Informed Consent Form (ICF); Willing and able to participate in procedures required by the trial, including examinations and follow-ups; Male, aged ≥ 18 years;
- Histologically or cytologically confirmed prostate cancer, with failure of standard treatment, refusal of standard treatment, no available standard treatment, or disease progression after refractory previous treatments, or no available treatment options according to current guidelines:
- Patients who have not received, refused to receive, or progressed after receiving at least 1 but no more than 2 taxane-based treatments. The taxane treatment regimen must include exposure to taxanes for at least 2 cycles. If the subject has only received one type of taxane and the doctor deems that he is not suitable for a second taxane treatment regimen (e.g., due to assessment of old age or health status indicating non-frailty or intolerance, etc.), he may also be included; Patients who have progressed after receiving at least one novel androgen-targeted drug (such as abiraterone, enzalutamide);
- Meet the Prostate Cancer Working Group 3 (PCWG3) criteria for diagnosis of metastatic castration-resistant prostate cancer (mCRPC), including:
- Serum testosterone reaches castration level (serum testosterone < 50 ng/dL or 1.7 nmol/L);
- And at least one of the following:
Show all 13Show fewer
- Serum PSA progression: PSA > 1 ng/mL, and PSA increases consecutively twice at 1-week intervals, with both values exceeding 50% of the lowest value; or bone scan indicates ≥ 2 new bone lesions; or CT or MRI indicates progression of soft tissue lesions (RECIST 1.1) Confirmed as PSMA-positive by 68Ga-PSMA PET/CT scan; At least one measurable lesion (RECIST 1.1); Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2; Expected survival > 6 months;
- Sufficient organ function:
- Bone marrow function: neutrophil count ≥ 1.5 × 109/L; white blood cell count ≥ 2.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 90 g/L;
- Liver function: total bilirubin ≤ 1.5 × ULN; albumin ≥ 30 g/L; ALT and AST < 3 × ULN in subjects without liver metastasis; < 5 × ULN in those with liver metastasis;
- Renal function: creatinine clearance ≥ 60 mL/min calculated by the Cockcroft-Gault formula;
- Coagulation function: INR ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 2 × ULN (for patients not receiving anticoagulant therapy or receiving stable-dose anticoagulants); All clinically significant toxic reactions related to previous anti-tumor treatments (such as chemotherapy, radiotherapy, etc.) have recovered to ≤ Grade 1 (CTCAE V5.0) (except alopecia).
- Agree to take radiation protection measures as directed by the doctor during the trial.
Who cannot join
- Unable to tolerate imaging procedures; Having received other investigational drugs or devices within 4 weeks prior to screening; Having received any of the following treatments within 6 months prior to administration: radium-223, strontium-89, samarium-153, rhenium-188, or hemibody radiotherapy; Having previously received PSMA-targeted radioligand therapy; or having received systemic anticancer therapy such as radiotherapy, chemotherapy, immunotherapy, or biotherapy within 4 weeks prior to the first administration; Having experienced grade 4 myelosuppression after previous anticancer treatment, or grade 3 myelosuppression that required more than 6 weeks to recover; Planning to use cytotoxic chemotherapeutic drugs, antitumor immunotherapy, radioligand therapy, or other similar antitumor drugs during the trial; Having used blood products, albumin, etc. within half a month prior to administration to make the subject meet the inclusion criteria;
- Having brain metastases, meningiomas, or other central nervous system metastases at screening, except for the following cases:
- For asymptomatic brain metastases, where the metastatic lesions are limited to the supratentorial and/or cerebellum (i.e., no metastases in the midbrain, pons, medulla oblongata, or spinal cord), no corticosteroid treatment is needed, and there are no brain metastases with a long diameter > 1.5 cm, the subject can participate in the study; For symptomatic brain metastases, those who have received treatment and whose lesions are confirmed to be stable for more than 4 weeks by imaging can participate in the study; Having other malignant tumors within 5 years (except for locally treated malignant tumors in situ, such as basal cell or squamous cell skin cancer); Having superscan; Having symptomatic spinal cord compression or expected to develop spinal cord compression; Having previously received external beam radiation therapy (EBRT) targeting extensive bone marrow (>25%); Having undergone allogeneic organ transplantation and requiring immunosuppressive therapy;
- Having severe heart disease at screening, including but not limited to the following:
- QTcF > 470 ms or a history of long QTc; Having myocardial infarction, angina pectoris, coronary artery bypass grafting, etc. within 6 months prior to screening, which the investigator deems unsuitable for inclusion; Having any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities at screening, which, in the investigator's judgment, reasonably suggest a disease or state unsuitable for the use of the study drug, may affect the interpretation of study results, or put the subject at high risk; Having poorly controlled bladder outlet obstruction or urinary incontinence at screening; Having positive hepatitis C virus antigen (HCVAg) or human immunodeficiency virus antibody (HIV) at screening; For those with positive hepatitis B surface antigen (HBsAg) at screening, hepatitis B virus deoxyribonucleic acid (HBV-DNA) testing is required; if the investigator determines that the patient is in the active viral replication stage, they cannot be included; Having active infection prior to administration; Having poor venous conditions at screening and unable to tolerate blood sample collection; Having known allergies to protein and/or polypeptide drugs, or to structural analogs of this product or other excipients; Having a history of drug or alcohol abuse within one year prior to screening, or a long-term history of drug addiction; Failing to take effective contraceptive measures during sexual activity during the trial and within 6 months after the last administration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Prostate cancer is one of the most common malignant tumors in the urinary and male reproductive systems. According to the 2020 edition of the Global Cancer Statistics Report published by the WHO International Agency for Research on Cancer in February 2021, newly diagnosed prostate cancer cases worldwide accounted for 7.3% of all malignant tumors in 2020, with an incidence rate ranking third after breast cancer and lung cancer. Deaths from prostate cancer accounted for 3.8% of all malignant tumor deaths, ranking eighth. In January 2019, the National Cancer Center released the latest incidence and mortality data of malignant tumors in China in 2015. Among them, there were 72,000 new prostate cancer cases, with an incidence rate of 10.23 per 100,000, ranking sixth among male malignant tumors; 31,000 deaths, with a mortality rate of 4.36 per 100,000, ranking tenth among male malignant tumors. Compared with European and American countries, prostate cancer in China has a relatively high mortality rate, mainly because most patients are diagnosed at an advanced stage. "Early diagnosis and early treatment" are important means to prolong the survival period and reduce the mortality rate of prostate cancer patients. Currently, the diagnostic methods for prostate cancer mainly include digital rectal examination, tumor markers, imaging examinations, and prostate biopsy.
Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein secreted by prostate epithelial cells, which is highly expressed in the cell membrane of prostate cancer cells and their metastases. PSMA is also weakly expressed in normal tissues such as the small intestine, brain, kidneys (proximal convoluted tubules), duodenal mucosa, parotid gland, and submandibular gland, but only at 1/1000 to 1/100 of the level in prostate cancer. Bostwick et al. used the PSMA-targeting antibody 7E11-C5 to detect tissues from 184 patients with prostate cancer lesions and found that the staining intensity was higher in prostate cancer tissues with higher Gleason scores. Subsequent studies by Silver et al. also found that the expression level of PSMA in prostate cancer tissues is much higher than that in normal prostate tissues, and its expression level is significantly correlated with the pathological stage of prostate cancer, with an expression rate of up to 96%-98% in lymph node metastases. The specific high expression of PSMA in cancer tissues makes it an important target for the diagnosis and treatment of prostate cancer, and a large number of radioactive molecular probes have been developed targeting this target for the diagnosis of prostate cancer, showing good target affinity.
Read more
The properties of different PSMA radiotracers vary slightly. Inhibitors of PSMA are mainly divided into three categories: phosphorous-based, thiol-based, and urea-based. Among them, the most widely used PSMA PET imaging agents are urea-based small molecules, such as 68Ga-PSMA-11, 68Ga-PSMA-617, 68Ga-PSMA-I\&T, 18F-DCFBC, 18F-DCFPyL, and 18F-PSMA-1007. Multiple studies have shown that compared with other PET imaging modalities or traditional imaging, PSMA PET imaging has significant advantages, including higher specificity, sensitivity, and positive predictive value.
68Ga-labeled PSMA ligands, as the first PSMA PET imaging agents applied to prostate cancer, have shown promising prospects in tumor localization, local staging, detection of biochemical recurrence (BCR), metastasis detection, and guiding treatment. Among these ligands, PSMA-11 is the most clinically used. 68Ga-PSMA-11 was approved by the FDA in December 2020. It is very helpful for prostate cancer patients with suspected metastasis or recurrence. For suspected metastases and recurrence, it can specifically bind to PSMA, clearly visualize lesions in PET imaging, accurately detect potential foci, provide important diagnostic basis for clinical practice, and assist doctors in judging disease progression and formulating effective treatment plans.
Another similar product, Pluvicto, was approved by the FDA in March 2022. It is used for patients with suspected metastatic prostate cancer scheduled for initial radical treatment, patients with suspected recurrent prostate cancer with elevated PSA levels, and screening metastatic prostate cancer patients eligible for 177Lu-PSMA-617 targeted therapy.
In summary, this product shares the same target and nuclide (68Ga) as Pluvicto, and is expected to have obvious diagnostic performance in PSMA-positive prostate cancer. The experimental results of Pluvicto have demonstrated acceptable safety and good effectiveness of the drug, thus ensuring the safety and effectiveness of this probe.
- Conditions
- PET CT
- Being tested
- Radioactive drugs are administered through intravenous injection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radioactive drugs are administered through intravenous injection.Drug
[68Ga]DOTA-IR-780-C-4 is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 h,2 h and 3 h after injection
| Study group | Role | What they receive |
|---|---|---|
| PET imaging of primary and metastatic lesions in prostate cancer patients | Experimental | [68Ga]DOTA-IR-780-C-4 is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 h, 2 h and 3 h after injection Receives: Drug: Radioactive drugs are administered through intravenous injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dection performance of radiotracer [68Ga]DOTA-IR-780-C-4
precise PET imaging and diagnosis of primary and metastatic lesions in prostate cancer patients
Measured: 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start29 Oct 2024
- Primary completion16 Dec 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET CTStudies 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiangnan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162779
- Sponsor's protocol ID
- LS2025002
- Other IDs
- 22274074
- Acronym
- PSMA
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protecting patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [68Ga]DOTA-IR-780-C-4 in PET Imaging Studies for PSMA-Positive Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT07162779
- Acronym / sponsor ID
- PSMA / LS2025002
- Conditions
- PET CT
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiangnan UniversityUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 16 Dec 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 9 Sep 2025 (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 cancer is one of the most common malignant tumors in the urinary and male reproductive systems. According to the 2020 edition of the Global Cancer Statistics Report published by the WHO International Agency for Research on Cancer in February 2021, newly diagnosed prostate cancer cases worldwide accounted for 7.3% of all malignant tumors in 2020, with an incidence rate ranking third after breast cancer and lung cancer. Deaths from prostate cancer accounted for 3.8% of all malignant tumor deaths, ranking eighth. In January 2019, the National Cancer Center released the latest incidence and mortality data of malignant tumors in China in 2015. Among them, there were 72,000 new prostate cancer cases, with an incidence rate of 10.23 per 100,000, ranking sixth among male malignant tumors; 31,000 deaths, with a mortality rate of 4.36 per 100,000, ranking tenth among male malignant tumors. Compared with European and American countries, prostate cancer in China has a relatively high mortality rate, mainly because most patients are diagnosed at an advanced stage. "Early diagnosis and early treatment" are important means to prolong the survival period and reduce the mortality rate of prostate cancer patients. Currently, the diagnostic methods for prostate cancer mainly include digital rectal examination, tumor markers, imaging examinations, and prostate biopsy.
Prostate-specific membrane antigen (PSMA) is a type II transmembrane glycoprotein secreted by prostate epithelial cells, which is highly expressed in the cell membrane of prostate cancer cells and their metastases. PSMA is also weakly expressed in normal tissues such as the small intestine, brain, kidneys (proximal convoluted tubules), duodenal mucosa, parotid gland, and submandibular gland, but only at 1/1000 to 1/100 of the level in prostate cancer. Bostwick et al. used the PSMA-targeting antibody 7E11-C5 to detect tissues from 184 patients with prostate cancer lesions and found that the staining intensity was higher in prostate cancer tissues with higher Gleason scores. Subsequent studies by Silver et al. also found that the expression level of PSMA in prostate cancer tissues is much higher than that in normal prostate tissues, and its expression level is significantly correlated with the pathological stage of prostate cancer, with an expression rate of up to 96%-98% in lymph node metastases. The specific high expression of PSMA in cancer tissues makes it an important target for the diagnosis and treatment of prostate cancer, and a large number of radioactive molecular probes have been developed targeting this target for the diagnosis of prostate cancer, showing good target affinity.
The properties of different PSMA radiotracers vary slightly. Inhibitors of PSMA are mainly divided into three categories: phosphorous-based, thiol-based, and urea-based. Among them, the most widely used PSMA PET imaging agents are urea-based small molecules, such as 68Ga-PSMA-11, 68Ga-PSMA-617, 68Ga-PSMA-I\&T, 18F-DCFBC, 18F-DCFPyL, and 18F-PSMA-1007. Multiple studies have shown that compared with other PET imaging modalities or traditional imaging, PSMA PET imaging has significant advantages, including higher specificity, sensitivity, and positive predictive value.
68Ga-labeled PSMA ligands, as the first PSMA PET imaging agents applied to prostate cancer, have shown promising prospects in tumor localization, local staging, detection of biochemical recurrence (BCR), metastasis detection, and guiding treatment. Among these ligands, PSMA-11 is the most clinically used. 68Ga-PSMA-11 was approved by the FDA in December 2020. It is very helpful for prostate cancer patients with suspected metastasis or recurrence. For suspected metastases and recurrence, it can specifically bind to PSMA, clearly visualize lesions in PET imaging, accurately detect potential foci, provide important diagnostic basis for clinical practice, and assist doctors in judging disease progression and formulating effective treatment plans.
Another similar product, Pluvicto, was approved by the FDA in March 2022. It is used for patients with suspected metastatic prostate cancer scheduled for initial radical treatment, patients with suspected recurrent prostate cancer with elevated PSA levels, and screening metastatic prostate cancer patients eligible for 177Lu-PSMA-617 targeted therapy.
In summary, this product shares the same target and nuclide (68Ga) as Pluvicto, and is expected to have obvious diagnostic performance in PSMA-positive prostate cancer. The experimental results of Pluvicto have demonstrated acceptable safety and good effectiveness of the drug, thus ensuring the safety and effectiveness of this probe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET imaging of primary and metastatic lesions in prostate cancer patients | Experimental | Drug: Radioactive drugs are administered through intravenous injection.[68Ga]DOTA-IR-780-C-4 is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 h, 2 h and 3 h after injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Able to understand and voluntarily sign the written Informed Consent Form (ICF); Willing and able to participate in procedures required by the trial, including examinations and follow-ups; Male, aged ≥ 18 years;
- Histologically or cytologically confirmed prostate cancer, with failure of standard treatment, refusal of standard treatment, no available standard treatment, or disease progression after refractory previous treatments, or no available treatment options according to current guidelines:
- Patients who have not received, refused to receive, or progressed after receiving at least 1 but no more than 2 taxane-based treatments. The taxane treatment regimen must include exposure to taxanes for at least 2 cycles. If the subject has only received one type of taxane and the doctor deems that he is not suitable for a second taxane treatment regimen (e.g., due to assessment of old age or health status indicating non-frailty or intolerance, etc.), he may also be included; Patients who have progressed after receiving at least one novel androgen-targeted drug (such as abiraterone, enzalutamide);
- Meet the Prostate Cancer Working Group 3 (PCWG3) criteria for diagnosis of metastatic castration-resistant prostate cancer (mCRPC), including:
- Serum testosterone reaches castration level (serum testosterone < 50 ng/dL or 1.7 nmol/L);
Key exclusion criteria (5 listed)
- Unable to tolerate imaging procedures; Having received other investigational drugs or devices within 4 weeks prior to screening; Having received any of the following treatments within 6 months prior to administration: radium-223, strontium-89, samarium-153, rhenium-188, or hemibody radiotherapy; Having previously received PSMA-targeted radioligand therapy; or having received systemic anticancer therapy such as radiotherapy, chemotherapy, immunotherapy, or biotherapy within 4 weeks prior to the first administration; Having experienced grade 4 myelosuppression after previous anticancer treatment, or grade 3 myelosuppression that required more than 6 weeks to recover; Planning to use cytotoxic chemotherapeutic drugs, antitumor immunotherapy, radioligand therapy, or other similar antitumor drugs during the trial; Having used blood products, albumin, etc. within half a month prior to administration to make the subject meet the inclusion criteria;
- Having brain metastases, meningiomas, or other central nervous system metastases at screening, except for the following cases:
- For asymptomatic brain metastases, where the metastatic lesions are limited to the supratentorial and/or cerebellum (i.e., no metastases in the midbrain, pons, medulla oblongata, or spinal cord), no corticosteroid treatment is needed, and there are no brain metastases with a long diameter > 1.5 cm, the subject can participate in the study; For symptomatic brain metastases, those who have received treatment and whose lesions are confirmed to be stable for more than 4 weeks by imaging can participate in the study; Having other malignant tumors within 5 years (except for locally treated malignant tumors in situ, such as basal cell or squamous cell skin cancer); Having superscan; Having symptomatic spinal cord compression or expected to develop spinal cord compression; Having previously received external beam radiation therapy (EBRT) targeting extensive bone marrow (>25%); Having undergone allogeneic organ transplantation and requiring immunosuppressive therapy;
- QTcF > 470 ms or a history of long QTc; Having myocardial infarction, angina pectoris, coronary artery bypass grafting, etc. within 6 months prior to screening, which the investigator deems unsuitable for inclusion; Having any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities at screening, which, in the investigator's judgment, reasonably suggest a disease or state unsuitable for the use of the study drug, may affect the interpretation of study results, or put the subject at high risk; Having poorly controlled bladder outlet obstruction or urinary incontinence at screening; Having positive hepatitis C virus antigen (HCVAg) or human immunodeficiency virus antibody (HIV) at screening; For those with positive hepatitis B surface antigen (HBsAg) at screening, hepatitis B virus deoxyribonucleic acid (HBV-DNA) testing is required; if the investigator determines that the patient is in the active viral replication stage, they cannot be included; Having active infection prior to administration; Having poor venous conditions at screening and unable to tolerate blood sample collection; Having known allergies to protein and/or polypeptide drugs, or to structural analogs of this product or other excipients; Having a history of drug or alcohol abuse within one year prior to screening, or a long-term history of drug addiction; Failing to take effective contraceptive measures during sexual activity during the trial and within 6 months after the last administration.
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 |
|---|---|---|
| Radioactive drugs are administered through intravenous injection.[68Ga]DOTA-IR-780-C-4 is administered through a superficial vein on the back of the hand. A PET/CT scan was performed approximately 1 h,2 h and 3 h after injection | Drug | PET imaging of primary and metastatic lesions in prostate cancer patients |
Primary outcome
The dection performance of radiotracer [68Ga]DOTA-IR-780-C-4
Time frame: 1-2 hours
precise PET imaging and diagnosis of primary and metastatic lesions in prostate cancer patients
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 9 Sep 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Protecting patient privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radioactive drugs are administered through intravenous injection. in people with PET CT, run by Affiliated Hospital of Jiangnan 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 13 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dection performance of radiotracer [68Ga]DOTA-IR-780-C-4 (time frame: 1-2 hours). 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 9 Sep 2025.