Breast TumorsNCT05976620
Clinical Study of 18F-FAPI-RGD in Breast Tumors
An observational study of Breast Tumors, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Tumors
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2023to 20 Feb 2024
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Patients with diagnosed or highly suspected breast cancer
Who may be able to join
- Age 18 and above
- No gender difference
- Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months
- Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010
Who cannot join
- Patients with a second primary tumor
- Pregnant or breastfeeding
- Severe liver or kidney disease
- Claustrophobia or other PET/CT scan contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
Departments of Nuclear Medicine, Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
About this study
Official title: Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin avβ3 (FAPI-RGD) in Breast Tumors
The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.
Read the detailed description
Breast cancer is the most common malignant disease in women worldwide.Early detection, accurate diagnosis and staging are the keys to effective treatment for breast cancer patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for acute and chronic infections and false-negative uptake for less aggressive histological subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is highly expressed in neovascular endothelial cells and tumor cells including breast cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion and metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD peptides in breast cancer patients has also been reported.
Several studies have confirmed that the heterodimer is superior to the corresponding monomer due to the polyvalent effect, thus improving the binding affinity and increasing the number of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.
- Conditions
- Breast Tumors
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between clinical indicators and PET/CT results
Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers，estrogen assay and 18F-FAPI-RGD PET/CT results
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start20 Jun 2023
- Primary completion15 Dec 2023
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast TumorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Wang, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976620
- Sponsor's protocol ID
- SichuanPPH-Breast cancer
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2023
- Last updated
- 15 Jul 2024
- 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 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of 18F Labeled Probe Targeting Fibroblast Activation Protein Inhibitor and Integrin avβ3 (FAPI-RGD) in Breast Tumors
- ClinicalTrials.gov ID
- NCT05976620
- Acronym / sponsor ID
- SichuanPPH-Breast cancer
- Conditions
- Breast Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 4 Aug 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.
The goal of this observational study is to learn about the value of 18F-FAPI-RGD PET/CT imaging in Breast Tumors. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.
Detailed description
Breast cancer is the most common malignant disease in women worldwide.Early detection, accurate diagnosis and staging are the keys to effective treatment for breast cancer patients.18F-FDG PET/CT has become an important imaging method for the diagnosis and staging of breast cancer.However,FDG PET has certain limitations, including false-positive uptake for acute and chronic infections and false-negative uptake for less aggressive histological subtypes of breast cancer.In a number of studies, 68Ga-FAPI PET was positively correlated with the pathological grade and end-stage of primary breast cancer lesions, and SUVmax could predict tumor grade, final stage and lymph node metastasis. Compared with 18F-FDG,68Ga-FAPI PET/CT had higher specificity and accuracy in judging lymph node metastasis.Integrin αvβ3 is highly expressed in neovascular endothelial cells and tumor cells including breast cancer, and plays an important role in regulating tumor growth, angiogenesis, local invasion and metastasis potential.The use of integrin αvβ3 specific imaging probes derived from RGD peptides in breast cancer patients has also been reported.
Several studies have confirmed that the heterodimer is superior to the corresponding monomer due to the polyvalent effect, thus improving the binding affinity and increasing the number of effective receptors.In order to simultaneously target FAP and integrin αvβ3, we synthesized the heterodimeric peptide FAPI-RGD from FAPI and RGD.FAPI-RGD is a heterodimeric peptide that targets FAP and αvβ3-integrin receptors. 68Ga-FAPI-RGDPET/CT imaging has been used in clinical imaging studies in patients with a variety of tumors.Therefore, we plan to use 18F-FAPI-RGD PET/CT imaging for the diagnosis and treatment of breast cancer, and preliminary experiments have confirmed that this examination has a good imaging effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diagnosed or highly suspected breast cancer
Key inclusion criteria (4 listed)
- Age 18 and above
- No gender difference
- Patients who have been diagnosed with, or are clinically highly suspected of, breast tumors and have had no other treatment within 3 months
- Tumor size (T), lymph node status (N), and overall clinical stage of diagnosed patients were determined according to the American Joint Committee on Cancer criteria revised in 2010
Key exclusion criteria (4 listed)
- Patients with a second primary tumor
- Pregnant or breastfeeding
- Severe liver or kidney disease
- Claustrophobia or other PET/CT scan contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between clinical indicators and PET/CT results
Time frame: 2 months
Correlation of Immunohistochemical indexes, ultrasound, X-ray, CT, MRI, tumor markers，estrogen assay and 18F-FAPI-RGD PET/CT results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
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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.
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?
An observational study of Breast Tumors, run by Sichuan Provincial People's 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 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: finished, as of the sponsor's last update on 15 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between clinical indicators and PET/CT results (time frame: 2 months). 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 15 Jul 2024.