Health TrialsbyHealthPanel

Target-specific immunoPET Imaging of Breast Cancer

ConditionsBreast CancerBreast NeoplasmsBreast Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorRenJi Hospital

About this trial

The aim of this study is to establish and optimize the Trop2/HER2-targeted PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in breast cancer will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years old and of female gender；

Histologically confirmed diagnosis of breast cancer or suspected breast cancer by diagnostic imaging;

Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

Disqualifiers

Pregnancy；

Severe hepatic and renal insufficiency;

History of serious surgery in the last month;

Allergic to antibody or single-domain antibody radiopharmaceuticals.

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]F-RESCA-RT4

    Drug

    Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RT4 injection.

  • [18F]F-RESCA-RB14

    Drug

    Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]F-RESCA-RB14. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]F-RESCA-RB14 injection.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Trop2/HER2-targeted immunoPET imagingExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14

Measurement of the overall biodistribution of above probes in normal tissues and organs.

Time frame
1 day from injection of the tracer
2

Standardized uptake value (SUV)

Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4/ \[18F\]F-RESCA-RB14 in the included subjects' primary and/or metastatic lesions.

Time frame
1 day from injection of the tracer
3

Radiation dosimetry of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14

Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.

Time frame
1 day from injection of the tracer
4

The correlation between Trop2 expression and [18F]F-RESCA-RT4 uptake value

The Standardized uptake value (SUV) of \[18F\]F-RESCA-RT4 will be calculated, and the correlation between pathological results and tumor uptake of\[18F\]F-RESCA-T4 will be analyzed.

Time frame
60 days

Secondary outcomes

1

The predictive value of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 in the course of targeted therapies

Baseline and follow-up \[18F\]F-RESCA-RT4/ \[18F\]F-RESCA-RB14 immunoPET imaging in targeted therapy will be investigated in this setting to determine the value of Trop2/HER2 immunoPET imaging in predicting or evaluating treatment responses.

Time frame
3-6 months
2

Trop2/HER2-targeted immunPET in changing clinical decision-making for patients with breast cancer

After analyzing the imaging parameters and diagnostic/predictive value of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT, we will also investigate how clinical use of \[18F\]F-RESCA-RT4/\[18F\]F-RESCA-RB14 PET/CT changes clinical decision-making for patients with breast cancer. Joint efforts from nuclear medicine physicians, breast surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.

Time frame
3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now