Prostate Cancer MetastaticPhase 1/2NCT05627778
68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis
A Phase 1/2 study testing 68Ga-PSMA-11 and 68Ga-P15-041 in people with Prostate Cancer Metastatic, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Tumor bone metastasis refers to the metastasis of malignant tumors to the bone through lymph, blood or direct invasion to generate daughter tumors, which is the most common bone tumor. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer Metastatic
- What is being tested?
- 68Ga-PSMA-11 and 68Ga-P15-041
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2022
- 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 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed suspected prostate bone metastasis patients;
- 68Ga-PSMA-11 and 68Ga-P15-041 PET/CT within one week;
- signed written consent.
Who cannot join
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Zhaohui Zhu, Doc., 86-13611093752, 13611093752@163.com
Jiarou Wang, MD., 86-13628477019, ChristinaWang97@163.com
About this study
Official title: A Head-to-head Comparison of 68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis
Tumor bone metastasis refers to the metastasis of malignant tumors to the bone through lymph, blood or direct invasion to generate daughter tumors, which is the most common bone tumor. More than 40% of patients with malignant tumors will have bone metastasis, among which breast cancer, prostate cancer is more common, once the tumor cells occur bone metastasis, it means that the disease enters the advanced stage, posing a serious threat to the life safety of patients, therefore, early diagnosis of various primary malignant tumor bone metastases, can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 ([68Ga]Ga-HBED-CC-BP) based on existing phosphonate-targeting molecular probes (Figure 1). Data from preclinical studies indicate that P15-041 shows additional advantages in rapid and easy complex formation compared to current [68Ga]Ga-BPAMD, [68Ga]Ga-NO2AP-BP, [68Ga]Ga-DOTA- (ZOL). In vivo experiments, P15-041 showed good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. [13] prepared multiple clinical doses of P15-041 and successfully evaluated it in patients, followed by intravenous P15-041, followed by a whole body PET/CT scan. Robert K. Doot et al. conducted dosimetric experiments on P15-041, analyzed the radioactive distribution of the drug in normal organs and the dynamic change of the dose of the drug in the body over time, and the results showed that P15-041 had high uptake in the bladder wall and bone cortex, blood and other tissues cleared quickly, and there was obvious radioactive enrichment in the myocardium in the early stage of imaging, and P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
Read the detailed description
Tumor bone metastasis (Tumor Bone Metastasis) refers to the metastasis of malignant tumor to the bone through lymphatic, blood or direct infiltration, resulting in sub-tumor, which is the most common bone tumor. More than 40% of patients with malignant tumors will develop bone metastasis, among which breast cancer and prostate cancer are more common. Once bone metastasis occurs in tumor cells, it means that the disease has entered an advanced stage and poses a serious threat to the life safety of patients. Therefore, early diagnosis Bone metastases from various primary malignant tumors can lay the foundation for the clinical implementation of effective treatment measures. At present, single photon emission computer-aided tomography (SPECT) technetium-99 (99mTc)-methylenediphos-phonate (MDP) is the preferred method for early diagnosis of tumor bone metastases , but benign bone Disease (such as bone degeneration, trauma, inflammatory response) and reactive changes during treatment ((scintillation phenomenon) can also be manifested as abnormal radioactive concentrations, with the possibility of false positives . Positron emission tomography Imaging (PET) technology is a nuclear medicine imaging method that integrates anatomical images of diseases and functional metabolism. It combines radioisotopes with compounds to achieve the function of imaging the metabolism of targeted substances. Compared with other imaging methods, PET molecular probes have higher sensitivity. Clinically, [18F]F-FDG PET/CT is commonly used to observe the metabolic status of bone metastases, which can show bone metastases that have not yet undergone osteogenesis or osteolysis. Vine-labeled phosphonates are bone imaging agents commonly used clinically to evaluate bone diseases such as infection (osteomyelitis), noninfectious inflammation (arthritis), trauma, metabolic bone disease, benign and malignant tumors, and metastases. ), the imaging agent reaches the bones of the whole body with the blood flow through intravenous injection, and is distributed in the bone tissue through ion exchange and chemical adsorption with the hydroxyapatite crystals in the bone, and the newly formed collagen has a higher effect on the bone imaging agent. Recent studies have shown that, the uptake mechanism of radionuclide-labeled phosphonates such as [99mTc]Tc-DPD, [99mTc]Tc-HMDP and [99mTc]Tc-PYP in amyloid myocardial deposition It is not fully understood, but some investigators have evaluated biopsies and found that microcalcifications are often present in cardiac amyloid deposits and may be associated with positive phosphonate imaging. However, [99mTc]Tc imaging agents are still not effective for Quantitative assessment of amyloid deposition. Recently, with the successful application of 68Ga-somatostatin receptor imaging agents in PET/CT, people have gradually shifted their attention to the "new generation" positron nuclides 68Ga, 68Ge /68Ga radionuclide generator can prepare 68Ga based PET tracer without adjacent cyclotron, in addition, 68Ga excellent physical properties (t1/2: 68min; 89%β+, 1.92mev maximum energy) Suitable for PET imaging, therefore, the development of bisphosphonates labeled with 68Ga will meet the need for a source of PET tracers.
Based on the existing phosphonate-targeted molecular probes, the Hank F. Kung laboratory at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 ([68Ga]Ga-HBED-CC-BP). Preclinical data show that P15-041 exhibits rapid and facile complex formation compared to current [68Ga]Ga-BPAMD, [68Ga]Ga-NO2AP-BP, [68Ga]Ga-DOTA-(ZOL) an additional advantage. In in vivo experiments, P15-041 exhibited good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. [13] prepared various clinical doses of P15-041 and successfully evaluated them in patients who performed whole-body PET/CT scans after intravenous administration of P15-041. Robert K. Doot et al conducted a dosimetry test on P15-041, and analyzed the radioactive distribution of the drug in normal organs and the dynamic changes of the drug in vivo with time. The cortical bone uptake is high, the blood and other tissues are cleared quickly, and there is obvious radioactive enrichment in the myocardium in the early stage of imaging. P15-041 has the potential to become a new generation of excellent phosphonate molecular probes.
- Conditions
- Prostate Cancer Metastatic
- Being tested
- 68Ga-PSMA-11, 68Ga-P15-041
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-11Drug
Also called 68Ga-PSMA-11 injection
Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-11. Tracer doses of 68Ga- PSMA-11 will be used to image lesions of prostate cancer by PET/CT.
68Ga-P15-041Drug
Also called 68Ga-P15-041 injection
Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P15-041. Tracer doses of 68Ga- 15-041 will be used to image lesions of prostate cancer by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA-11 and 68Ga-P15-041 PET/ CT scan | Experimental | Patients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/ CT scan after intravenous administration of 68Ga- PSMA-11 and 68Ga-P15-041, respectively. Receives: Drug: 68Ga-PSMA-11; Drug: 68Ga-P15-041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection capability of bone metastasis
the bone metastasis number detected by 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/ CT
Measured: through study completion, an average of 1 year
SUVmax of bone metastasis
the tumor uptake on 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/CT
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
PSMA expression and SUV
Correlation between PSMA expression and SUV in PET
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 posted28 Nov 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer MetastaticStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaohui Zhu, Doc., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05627778
- Sponsor's protocol ID
- PUMCH-NM-11/041
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2022
- Last updated
- 28 Nov 2022
- 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 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Head-to-head Comparison of 68Ga-P15-041 and 68Ga-PSMA-11 PET/CT Imaging in the Same Group of Prostate Bone Metastasis
- ClinicalTrials.gov ID
- NCT05627778
- Acronym / sponsor ID
- PUMCH-NM-11/041
- Conditions
- Prostate Cancer Metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 28 Nov 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.
Tumor bone metastasis refers to the metastasis of malignant tumors to the bone through lymph, blood or direct invasion to generate daughter tumors, which is the most common bone tumor. More than 40% of patients with malignant tumors will have bone metastasis, among which breast cancer, prostate cancer is more common, once the tumor cells occur bone metastasis, it means that the disease enters the advanced stage, posing a serious threat to the life safety of patients, therefore, early diagnosis of various primary malignant tumor bone metastases, can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 ([68Ga]Ga-HBED-CC-BP) based on existing phosphonate-targeting molecular probes (Figure 1). Data from preclinical studies indicate that P15-041 shows additional advantages in rapid and easy complex formation compared to current [68Ga]Ga-BPAMD, [68Ga]Ga-NO2AP-BP, [68Ga]Ga-DOTA- (ZOL). In vivo experiments, P15-041 showed good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. [13] prepared multiple clinical doses of P15-041 and successfully evaluated it in patients, followed by intravenous P15-041, followed by a whole body PET/CT scan. Robert K. Doot et al. conducted dosimetric experiments on P15-041, analyzed the radioactive distribution of the drug in normal organs and the dynamic change of the dose of the drug in the body over time, and the results showed that P15-041 had high uptake in the bladder wall and bone cortex, blood and other tissues cleared quickly, and there was obvious radioactive enrichment in the myocardium in the early stage of imaging, and P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
Detailed description
Tumor bone metastasis (Tumor Bone Metastasis) refers to the metastasis of malignant tumor to the bone through lymphatic, blood or direct infiltration, resulting in sub-tumor, which is the most common bone tumor. More than 40% of patients with malignant tumors will develop bone metastasis, among which breast cancer and prostate cancer are more common. Once bone metastasis occurs in tumor cells, it means that the disease has entered an advanced stage and poses a serious threat to the life safety of patients. Therefore, early diagnosis Bone metastases from various primary malignant tumors can lay the foundation for the clinical implementation of effective treatment measures. At present, single photon emission computer-aided tomography (SPECT) technetium-99 (99mTc)-methylenediphos-phonate (MDP) is the preferred method for early diagnosis of tumor bone metastases , but benign bone Disease (such as bone degeneration, trauma, inflammatory response) and reactive changes during treatment ((scintillation phenomenon) can also be manifested as abnormal radioactive concentrations, with the possibility of false positives . Positron emission tomography Imaging (PET) technology is a nuclear medicine imaging method that integrates anatomical images of diseases and functional metabolism. It combines radioisotopes with compounds to achieve the function of imaging the metabolism of targeted substances. Compared with other imaging methods, PET molecular probes have higher sensitivity. Clinically, [18F]F-FDG PET/CT is commonly used to observe the metabolic status of bone metastases, which can show bone metastases that have not yet undergone osteogenesis or osteolysis. Vine-labeled phosphonates are bone imaging agents commonly used clinically to evaluate bone diseases such as infection (osteomyelitis), noninfectious inflammation (arthritis), trauma, metabolic bone disease, benign and malignant tumors, and metastases. ), the imaging agent reaches the bones of the whole body with the blood flow through intravenous injection, and is distributed in the bone tissue through ion exchange and chemical adsorption with the hydroxyapatite crystals in the bone, and the newly formed collagen has a higher effect on the bone imaging agent. Recent studies have shown that, the uptake mechanism of radionuclide-labeled phosphonates such as [99mTc]Tc-DPD, [99mTc]Tc-HMDP and [99mTc]Tc-PYP in amyloid myocardial deposition It is not fully understood, but some investigators have evaluated biopsies and found that microcalcifications are often present in cardiac amyloid deposits and may be associated with positive phosphonate imaging. However, [99mTc]Tc imaging agents are still not effective for Quantitative assessment of amyloid deposition. Recently, with the successful application of 68Ga-somatostatin receptor imaging agents in PET/CT, people have gradually shifted their attention to the "new generation" positron nuclides 68Ga, 68Ge /68Ga radionuclide generator can prepare 68Ga based PET tracer without adjacent cyclotron, in addition, 68Ga excellent physical properties (t1/2: 68min; 89%β+, 1.92mev maximum energy) Suitable for PET imaging, therefore, the development of bisphosphonates labeled with 68Ga will meet the need for a source of PET tracers.
Based on the existing phosphonate-targeted molecular probes, the Hank F. Kung laboratory at the University of Pennsylvania has developed a new generation of 68Ga-labeled radiopharmaceutical P15-041 ([68Ga]Ga-HBED-CC-BP). Preclinical data show that P15-041 exhibits rapid and facile complex formation compared to current [68Ga]Ga-BPAMD, [68Ga]Ga-NO2AP-BP, [68Ga]Ga-DOTA-(ZOL) an additional advantage. In in vivo experiments, P15-041 exhibited good bone resorption and rapid renal excretion in normal mice. Haiyan Hong et al. [13] prepared various clinical doses of P15-041 and successfully evaluated them in patients who performed whole-body PET/CT scans after intravenous administration of P15-041. Robert K. Doot et al conducted a dosimetry test on P15-041, and analyzed the radioactive distribution of the drug in normal organs and the dynamic changes of the drug in vivo with time. The cortical bone uptake is high, the blood and other tissues are cleared quickly, and there is obvious radioactive enrichment in the myocardium in the early stage of imaging. P15-041 has the potential to become a new generation of excellent phosphonate molecular probes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA-11 and 68Ga-P15-041 PET/ CT scan | Experimental | Drug: 68Ga-PSMA-11, Drug: 68Ga-P15-041Patients of Prostate cancer PET/CT imaging: In two consecutive days each patient underwent a PET/ CT scan after intravenous administration of 68Ga- PSMA-11 and 68Ga-P15-041, respectively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed suspected prostate bone metastasis patients;
- 68Ga-PSMA-11 and 68Ga-P15-041 PET/CT within one week;
- signed written consent.
Key exclusion criteria (2 listed)
- known allergy against PSMA;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
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-PSMA-11Also: 68Ga-PSMA-11 injectionIntravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-11. Tracer doses of 68Ga- PSMA-11 will be used to image lesions of prostate cancer by PET/CT. | Drug | 68Ga-PSMA-11 and 68Ga-P15-041 PET/ CT scan |
| 68Ga-P15-041Also: 68Ga-P15-041 injectionIntravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P15-041. Tracer doses of 68Ga- 15-041 will be used to image lesions of prostate cancer by PET/CT. | Drug | 68Ga-PSMA-11 and 68Ga-P15-041 PET/ CT scan |
Primary outcome
detection capability of bone metastasis
Time frame: through study completion, an average of 1 year
the bone metastasis number detected by 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/ CT
SUVmax of bone metastasis
Time frame: through study completion, an average of 1 year
the tumor uptake on 68Ga-P15-041 PET/CT for prostate cancer in comparison with 68Ga-PSMA-11 PET/CT
1 secondary outcome
PSMA expression and SUV
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 28 Nov 2022.
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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, Doc. principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-PSMA-11 and 68Ga-P15-041 in people with Prostate Cancer Metastatic, run by Peking Union Medical College 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: status not confirmed, as of the sponsor's last update on 28 Nov 2022. 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 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, Doc. (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?
detection capability of bone metastasis (time frame: through study completion, an average of 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?
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 28 Nov 2022.