Clear Cell Sarcoma of Soft TissueNCT05963035
Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
A study testing 18F-PFPN in people with Clear Cell Sarcoma of Soft Tissue, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
This study is a prospective monocentric study aimed to evaluate the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN PET/MR imaging will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Sarcoma of Soft Tissue
- What is being tested?
- 18F-PFPN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age 18 years or above), regardless of gender;
- Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue (supporting evidence including visual examination, MRI, CT, ultrasound, and histopathological examination, etc.) ;
- Patients who agree to undergo both 18F-PFPN and 18F-FDG PET imaging.
Who cannot join
- Acute systemic diseases and electrolyte disturbances;
- Patients who plan to get pregnant within six months or are pregnant or breastfeeding;
- The patient or his/her legal representative is unable or unwilling to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China, Hubei Province
Wuhan, Hubei, 430022
Xiaoli Lan, +86-027-83692633, lxl730724@hotmail.com
About this study
This study is a prospective monocentric study aimed to evaluate the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN PET/MR imaging will be performed. PET/CT imaging will be performed in patients with contraindications to MR. Additionally, to compare the diagnostic efficacy with the traditional imaging agent 18F-FDG, patients will also undergo 18F-FDG PET imaging, and the two imaging intervals will be completed two days apart. The general information, clinical data, 18F-PFPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen, follow-up and other imaging examinations will be taken as evaluation references. This study plans to set the sample size as 10 cases.
Read the detailed description
Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that contain melanin and/or melanin precursors. Melanin is an important target for the diagnosis of clear cell sarcoma of soft tissue. 18F-PFPN, a highly specific melanin-targeting positron probe, has been proven to have excellent pharmacokinetic properties and good biological safety, and can sensitively detect tiny melanin-containing lesions. Therefore, 18F-PFPN PET imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue.
This study was designed as a prospective study to explore the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. In this study, patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo 18F-PFPN PET/MR imaging. PET/CT imaging will be performed in patients with contraindications to MR. The general information, clinical data, imaging data and histopathology results of patients will be collected. The efficiency of diagnosis and staging of 18F-PFPN was evaluated by comparing the gold standard pathological diagnosis and the general metabolic imaging agent 18F-FDG.
- Conditions
- Clear Cell Sarcoma of Soft Tissue
- Being tested
- 18F-PFPN
- Medical subject headings
- Sarcoma, Clear Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PFPNDrug
Also called 18F-PEG3-FPN
For patients clinically suspected or confirmed clear cell sarcoma of soft tissue, integrated PET/MR or PET/CT imaging will be performed using targeted melanin-specific imaging agent 18F-PFPN. Meanwhile, multiple parameters will be compared with the general imaging agent 18F-FDG.
| Study group | Role | What they receive |
|---|---|---|
| 18F-PFPN PET | Experimental | A positron probe for the targeted melanin Receives: Drug: 18F-PFPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start21 Jun 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Sarcoma of Soft TissueStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoli Lan, Study director, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963035
- Sponsor's protocol ID
- XLan-0409
- Status last verified
- Jun 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Kang F, Zheng H, Gai Y, Wang J, Lan X. Melanin-targeted [18F]-PFPN PET imaging may shed light for clear cell sarcoma. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):196-201. doi: 10.1007/s00259-023-06439-2. Epub 2023 Sep 16.
PubMed 37714979
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of 18F-PFPN PET Imaging in Diagnosis and Staging of Clear Cell Sarcoma of Soft Tissue
- ClinicalTrials.gov ID
- NCT05963035
- Acronym / sponsor ID
- XLan-0409
- Conditions
- Clear Cell Sarcoma of Soft Tissue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Jul 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.
This study is a prospective monocentric study aimed to evaluate the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited and 18F-PFPN PET/MR imaging will be performed. PET/CT imaging will be performed in patients with contraindications to MR. Additionally, to compare the diagnostic efficacy with the traditional imaging agent 18F-FDG, patients will also undergo 18F-FDG PET imaging, and the two imaging intervals will be completed two days apart. The general information, clinical data, 18F-PFPN and 18F-FDG PET/MR or PET/CT imaging results and other imaging data of the patients will be collected. The histopathology of the biopsy or surgical specimen, follow-up and other imaging examinations will be taken as evaluation references. This study plans to set the sample size as 10 cases.
Detailed description
Clear cell sarcoma of soft tissue is a rare malignancy derived from neural crest cells that contain melanin and/or melanin precursors. Melanin is an important target for the diagnosis of clear cell sarcoma of soft tissue. 18F-PFPN, a highly specific melanin-targeting positron probe, has been proven to have excellent pharmacokinetic properties and good biological safety, and can sensitively detect tiny melanin-containing lesions. Therefore, 18F-PFPN PET imaging is expected to be used in diagnosing and staging clear cell sarcoma of soft tissue.
This study was designed as a prospective study to explore the diagnosis and staging value of 18F-PFPN PET in clear cell sarcoma of soft tissue. In this study, patients with clinically suspected or confirmed clear cell sarcoma of soft tissue will be recruited to undergo 18F-PFPN PET/MR imaging. PET/CT imaging will be performed in patients with contraindications to MR. The general information, clinical data, imaging data and histopathology results of patients will be collected. The efficiency of diagnosis and staging of 18F-PFPN was evaluated by comparing the gold standard pathological diagnosis and the general metabolic imaging agent 18F-FDG.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-PFPN PET | Experimental | Drug: 18F-PFPNA positron probe for the targeted melanin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age 18 years or above), regardless of gender;
- Patients with clinically suspected or confirmed clear cell sarcoma of soft tissue (supporting evidence including visual examination, MRI, CT, ultrasound, and histopathological examination, etc.) ;
- Patients who agree to undergo both 18F-PFPN and 18F-FDG PET imaging.
Key exclusion criteria (3 listed)
- Acute systemic diseases and electrolyte disturbances;
- Patients who plan to get pregnant within six months or are pregnant or breastfeeding;
- The patient or his/her legal representative is unable or unwilling to sign the informed consent.
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 |
|---|---|---|
| 18F-PFPNAlso: 18F-PEG3-FPNFor patients clinically suspected or confirmed clear cell sarcoma of soft tissue, integrated PET/MR or PET/CT imaging will be performed using targeted melanin-specific imaging agent 18F-PFPN. Meanwhile, multiple parameters will be compared with the general imaging agent 18F-FDG. | Drug | 18F-PFPN PET |
Primary outcome
Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue
Time frame: 1 years
18F-PFPN and 18F-FDG PET/MR or PET/CT images will be analyzed by at least 2 physicians experienced in nuclear medicine and radiology. The general information, clinical, histopathological and imaging data of patients will be collected and analyzed to calculate the sensitivity and specificity of 18F-PFPN for diagnosis and staging in clear cell sarcoma of soft tissue.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 37714979Zhang X, Kang F, Zheng H, Gai Y, Wang J, Lan X. Melanin-targeted [18F]-PFPN PET imaging may shed light for clear cell sarcoma. Eur J Nucl Med Mol Imaging. 2023 Dec;51(1):196-201. doi: 10.1007/s00259-023-06439-2. Epub 2023 Sep 16.
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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.
Xiaoli Lan study director
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-PFPN in people with Clear Cell Sarcoma of Soft Tissue, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 27 Jul 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaoli Lan (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of 18F-PFPN PET for diagnosis and staging of clear cell sarcoma of soft tissue (time frame: 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963035, which also lists 1 linked publication.
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 Jul 2023.