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Breast CancerPhase 1/2NCT06715826

Target-specific immunoPET Imaging of Breast Cancer

A Phase 1/2 study testing [18F]F-RESCA-RT4 and [18F]F-RESCA-RB14 in people with Breast Cancer and Breast Neoplasms, run by RenJi Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
[18F]F-RESCA-RT4 and [18F]F-RESCA-RB14
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
21 Sep 2024to Nov 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • History of serious surgery in the last month;
  • Allergic to antibody or single-domain antibody radiopharmaceuticals.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Weijun Wei, Ph.D. & M.D. contact

15000083153

wwei@shsmu.edu.cn

Wenzhi Jia, Ph.D. & M.D. contact

18317076979

jwzdata@126.com

China1 site, 1 recruiting

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

    Weijun Wei, Ph.D. & M.D., 15000083153, wwei@shsmu.edu.cn

    Wenzhi Jia, Ph.D. & M.D., 18317076979, jwzdata@126.com

    Recruiting

Other trials in China

About this study

Official title: Development and Clinical Translation of immunoPET Imaging Probes for Breast Cancer

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.

Read the detailed description

Enrolled patients will undergo whole-body[18F]F-RESCA-RT4(Trop2-targeted imaging probes ) or [18F]F-RESCA-RB14(HER2-targeted imaging probes) PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively.

Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

Being tested
[18F]F-RESCA-RT4, [18F]F-RESCA-RB14
Keywords
Trop2, HER2, Breast Cancer, ImmunoPET
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]F-RESCA-RT4Drug

    Also called [18F]F-RT4

    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-RB14Drug

    Also called [18F]F-RB14

    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.

Study groups in NCT06715826
Study groupRoleWhat they receive
Trop2/HER2-targeted immunoPET imagingExperimentalEnrolled patients will undergo a Trop2/HER2-targeted immunoPET/CT scanning.
Receives: Drug: [18F]F-RESCA-RT4; Drug: [18F]F-RESCA-RB14

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 60 days

  5. The correlation between HER2 expression and [18F]F-RESCA-RB14 uptake value

    Standardized uptake value (SUV) of [18F]F-RESCA-RB14 will be calculated, and the correlation between pathological results and tumor uptake of [18F]F-RESCA-RB14 will be analyzed.

    Measured: 60 days

  6. Diagnostic value of Trop2/HER2-targeted immunPET in patients with breast cancer

    We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT in patients with breast cancer. We will also compare the diagnostic value of above probes with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., MRI). All the above goals will be achieved by analyzing the static/dynamic[18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of [18F]F-RESCA-RT4/[18F]F-RESCA-RB14 PET/CT for patients with breast cancer.

    Measured: 30 days

Secondary outcomes (2)

  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.

    Measured: 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.

    Measured: 3-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start21 Sep 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 1/2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06715826
Sponsor's protocol ID
KY2024-095-A
Status last verified
Jan 2026
First submitted
29 Nov 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing [18F]F-RESCA-RT4 and [18F]F-RESCA-RB14 in people with Breast Cancer and Breast Neoplasms, run by RenJi 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 3 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: looking for participants now, as of the sponsor's last update on 27 Jan 2026. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weijun Wei, Ph.D. & M.D. (15000083153, wwei@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodistribution of [18F]F-RESCA-RT4/ [18F]F-RESCA-RB14 (time frame: 1 day from injection of the tracer). The study lists 6 primary outcomes in all. 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 NCT06715826.

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 Jan 2026.

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