Breast CancerNCT05574920
Characterizing Breast Cancer With Al18F-NOTA-FAPI-04 PET/CT (PFB-02)
A study testing Al18F-NOTA-FAPI-04 PET/CT scan in people with Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Al18F-NOTA-FAPI-04 PET/CT scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2022to 1 Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years old;
- newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;
- BC clinical stagecT1-3 cN0-3 M0;
- no prior treatment for BC.
Who cannot join
- pregnancy;
- breastfeeding;
- patients who were unwilling to undergo PET/CT scans.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
Read the detailed description
Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Based on this characteristic, many small-molecule inhibitors of FAP (FAPIs) labeled with radioactive tracers (68Ga, 18F, or 177Lu) have been synthesized as theranostic radiotracers for cancer. Previous studies on FAPI PET/CT tumor imaging have focused on the 68Ga radionuclide rather than 18F. As 18F-labeled FAPI has more favorable physical properties, high production capacity, and good imaging characteristics, it may be an ideal agent for PET imaging. Therefore, this study aims to evaluate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Al18F-NOTA-FAPI-04 PET/CT scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al18F-NOTA-FAPI-04 PET/CT scanDiagnostic test
Patients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| Al18F-NOTA-FAPI-04 PET/CT | Experimental | Inject Al18F-NOTA-FAPI-04 and then perform PET/CT scan. Receives: Diagnostic Test: Al18F-NOTA-FAPI-04 PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance (1)
Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Clinical Stage
Clinical stage changed by Al18F-NOTA-FAPI-04 PET/CT compared to 18F-FDG PET/CT.
Measured: Through study completion, an average of 1 year
Diagnostic Performance (2)
Diagnostic performance of ALN metastasis of Al18F-NOTA-FAPI-04 PET/CT with or without previous biopsy on breast lesion.
Measured: Through study completion, an average of 1 year
Safety
Short-term adverse effects (AEs) after Al18F-NOTA-FAPI-04 injection.
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 posted12 Oct 2022
- Study start10 May 2022
- Primary completion31 Oct 2023
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574920
- Sponsor's protocol ID
- PekingUMCH-FAPI-BC-2
- Status last verified
- Dec 2023
- First submitted
- 7 Oct 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05574920
- Acronym / sponsor ID
- PekingUMCH-FAPI-BC-2
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 12 Oct 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.
Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
Detailed description
Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Based on this characteristic, many small-molecule inhibitors of FAP (FAPIs) labeled with radioactive tracers (68Ga, 18F, or 177Lu) have been synthesized as theranostic radiotracers for cancer. Previous studies on FAPI PET/CT tumor imaging have focused on the 68Ga radionuclide rather than 18F. As 18F-labeled FAPI has more favorable physical properties, high production capacity, and good imaging characteristics, it may be an ideal agent for PET imaging. Therefore, this study aims to evaluate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-NOTA-FAPI-04 PET/CT | Experimental | Diagnostic Test: Al18F-NOTA-FAPI-04 PET/CT scanInject Al18F-NOTA-FAPI-04 and then perform PET/CT scan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-80 years old;
- newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG;
- BC clinical stagecT1-3 cN0-3 M0;
- no prior treatment for BC.
Key exclusion criteria (3 listed)
- pregnancy;
- breastfeeding;
- patients who were unwilling to undergo PET/CT scans.
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 |
|---|---|---|
| Al18F-NOTA-FAPI-04 PET/CT scanPatients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer. | Diagnostic test | Al18F-NOTA-FAPI-04 PET/CT |
Primary outcome
Diagnostic Performance (1)
Time frame: Through study completion, an average of 1 year
Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound.
3 secondary outcomes
Clinical Stage
Time frame: Through study completion, an average of 1 year
Diagnostic Performance (2)
Time frame: Through study completion, an average of 1 year
Safety
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 29 Dec 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Li Huo, M.D. 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 study testing Al18F-NOTA-FAPI-04 PET/CT scan in people with Breast Cancer, 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 4 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 29 Dec 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?
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?
Diagnostic Performance (1) (time frame: Through study completion, an average of 1 year). 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 29 Dec 2023.