Bone TumorEarly Phase 1NCT06455722
[68Ga]Ga-P15-041 PET/CT in Variety of Bone Tumors
A Early Phase 1 study testing [68Ga]Ga-P15-041 in people with Bone Tumor and Bone Metastases, run by First Affiliated Hospital of Fujian Medical University at 1 site in China.
Trial summary
Bone tumors refer to tumors that occur in the bone or its accessory tissues. Benign bone tumors usually reveal a good prognosis, while malignant bone tumors develop rapidly, have a poor prognosis and high mortality. Malignant bone tumors are also classified as primary tumor and secondary metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bone Tumor, Bone Metastases
- What is being tested?
- [68Ga]Ga-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 Jan 2024to 31 Dec 2025
- Phase
- Early Phase 1
- 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
- suspected or confirmed primary bone tumors or metastatic bone tumors
- signed written consent
- available other examinations such as bone scan or enhanced CT within 2 weeks
Who cannot join
- pregnancy
- breastfeeding
- known allergy against bisphosphonate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005
Weibing Miao, MD, +86-0591-87981618, miaoweibing@126.com
Guochang Wang, MD, +86-0591-87981619, guochang1007@163.com
About this study
Official title: [68Ga]Ga-P15-041 PET/CT for Diagnosis and Prognostic Evaluation in Variety of Bone Tumors
Bone tumors refer to tumors that occur in the bone or its accessory tissues. Benign bone tumors usually reveal a good prognosis, while malignant bone tumors develop rapidly, have a poor prognosis and high mortality. Malignant bone tumors are also classified as primary tumor and secondary metastasis. Bone metastasis refers 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. Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 ([68Ga]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Series of research results showed that [68Ga]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, [68Ga]Ga-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
Read the detailed description
Bone tumors refer to tumors that occur in the bone or its accessory tissues. Benign bone tumors usually reveal a good prognosis, while malignant bone tumors develop rapidly, have a poor prognosis and high mortality. Malignant bone tumors are also classified as primary tumor and secondary metastasis. Bone metastasis refers 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. Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 ([68Ga]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Data from preclinical studies indicated that [68Ga]Ga-P15-041 shows additional advantages in rapid and easy complex formation compared to current agents. In preclinical experiments, [68Ga]Ga-P15-041 showed good bone resorption and rapid renal excretion in normal mice. Hong et al. prepared multiple clinical doses of [68Ga]Ga-P15-041 and successfully evaluated it in patients. Robert K. Doot et al. conducted dosemetric experiments on [68Ga]Ga-P15-041, and 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. Series of research results showed that [68Ga]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, [68Ga]Ga-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
- Conditions
- Bone Tumor, Bone Metastases
- Being tested
- [68Ga]Ga-P15-041
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-P15-041Drug
Also called [68Ga]Ga-P15-041 PET/CT
Intravenous injection of one dose of 111-148 MBq (3-4 mCi) [68Ga]Ga-P15-041. Tracer doses of [68Ga]Ga-P15-041 will be used to image lesions by PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-P15-041; PET/CT | Experimental | Perform PET/CT after injecting [68Ga]Ga-P15-041 Receives: Drug: [68Ga]Ga-P15-041 |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection capability
Record the number of bone tumor detected by [68Ga]Ga-P15-041 PET/CT, and compared it with other examinations such as bone scan and enhanced CT.
Measured: through study completion, an average of 6 months
tumor uptake
Measure the standard uptake value of focal lesions on [68Ga]Ga-P15-041 PET/CT.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
survival
Follow up and record the time for patient's survival. To investigate the relationship between initial tumor uptake of focal lesions and survival.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Fujian Medical UniversityThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Weibing Miao, MD, Principal investigator, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455722
- Sponsor's protocol ID
- FirstAHFujian-P15-041
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 12 Jun 2024
- Results posted
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68Ga]Ga-P15-041 PET/CT for Diagnosis and Prognostic Evaluation in Variety of Bone Tumors
- ClinicalTrials.gov ID
- NCT06455722
- Acronym / sponsor ID
- FirstAHFujian-P15-041
- Conditions
- Bone Tumor, Bone Metastases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Fujian Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Jun 2024 (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.
Bone tumors refer to tumors that occur in the bone or its accessory tissues. Benign bone tumors usually reveal a good prognosis, while malignant bone tumors develop rapidly, have a poor prognosis and high mortality. Malignant bone tumors are also classified as primary tumor and secondary metastasis. Bone metastasis refers 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. Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 ([68Ga]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Series of research results showed that [68Ga]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, [68Ga]Ga-P15-041 had the potential to become a new generation of excellent phosphonate molecular probes.
Detailed description
Bone tumors refer to tumors that occur in the bone or its accessory tissues. Benign bone tumors usually reveal a good prognosis, while malignant bone tumors develop rapidly, have a poor prognosis and high mortality. Malignant bone tumors are also classified as primary tumor and secondary metastasis. Bone metastasis refers 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. Early diagnosis of a various of bone tumors can lay the foundation for clinical implementation of effective treatment measures. The laboratory of Hank F. Kung at the University of Pennsylvania had developed a new generation of Gallium-68 labeled radiopharmaceutical P15-041 ([68Ga]Ga-P15-041) based on existing phosphonate-targeting molecular probes. Data from preclinical studies indicated that [68Ga]Ga-P15-041 shows additional advantages in rapid and easy complex formation compared to current agents. In preclinical experiments, [68Ga]Ga-P15-041 showed good bone resorption and rapid renal excretion in normal mice. Hong et al. prepared multiple clinical doses of [68Ga]Ga-P15-041 and successfully evaluated it in patients. Robert K. Doot et al. conducted dosemetric experiments on [68Ga]Ga-P15-041, and 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. Series of research results showed that [68Ga]Ga-P15-041 had high uptake in the bone cortex, blood and other tissues cleared quickly. Hence, [68Ga]Ga-P15-041 had 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]Ga-P15-041; PET/CT | Experimental | Drug: [68Ga]Ga-P15-041Perform PET/CT after injecting [68Ga]Ga-P15-041 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- suspected or confirmed primary bone tumors or metastatic bone tumors
- signed written consent
- available other examinations such as bone scan or enhanced CT within 2 weeks
Key exclusion criteria (3 listed)
- pregnancy
- breastfeeding
- known allergy against bisphosphonate
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]Ga-P15-041Also: [68Ga]Ga-P15-041 PET/CTIntravenous injection of one dose of 111-148 MBq (3-4 mCi) [68Ga]Ga-P15-041. Tracer doses of [68Ga]Ga-P15-041 will be used to image lesions by PET/CT. | Drug | [68Ga]Ga-P15-041; PET/CT |
Primary outcome
detection capability
Time frame: through study completion, an average of 6 months
Record the number of bone tumor detected by [68Ga]Ga-P15-041 PET/CT, and compared it with other examinations such as bone scan and enhanced CT.
tumor uptake
Time frame: through study completion, an average of 6 months
Measure the standard uptake value of focal lesions on [68Ga]Ga-P15-041 PET/CT.
1 secondary outcome
survival
Time frame: through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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. This study is not recruiting at the moment.
Weibing Miao, MD principal investigator
First Affiliated Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [68Ga]Ga-P15-041 in people with Bone Tumor and Bone Metastases, run by First Affiliated Hospital of Fujian Medical 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 3 inclusion and 3 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 12 Jun 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Weibing Miao, MD (+86-0591-87981618, miaoweibing@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection capability (time frame: through study completion, an average of 6 months). 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 12 Jun 2024.