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CancerPhase 1NCT06203119

Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

A Phase 1 study testing 68Ga-DOTA-BPP and 18F-FDG in people with Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective, single-center, open-label study aims to evaluate the safety, biodistribution, and tumor imaging characteristics of the novel ACE1-targeted PET radiotracer 68Ga-DOTA-BPP in patients with confirmed or suspected triple-negative breast cancer (TNBC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer
What is being tested?
68Ga-DOTA-BPP and 18F-FDG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
6 Mar 2024to 18 Dec 2025
Phase
Phase 1
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 to 75 years, inclusive; sex unrestricted.
  • Patients with triple-negative breast cancer (TNBC) or suspected TNBC who are scheduled to undergo pathological tissue biopsy or surgical treatment for the tumor in the near future (within 2 months).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Estimated life expectancy of ≥12 weeks.
  • Adequate hematologic, coagulation, hepatic, and renal function, defined as follows:
  • WBC ≥4.0 × 10⁹/L or neutrophil count ≥1.5 × 10⁹/L; PLT ≥100 × 10⁹/L; Hb ≥90 g/L; PT or APTT ≤1.5 × the upper limit of normal (ULN); Total bilirubin ≤1.5 × ULN; ALT and AST ≤2.5 × ULN, or ≤5 × ULN in patients with liver metastases; ALP ≤2.5 × ULN, or ≤4.5 × ULN in patients with bone or liver metastases; BUN ≤1.5 × ULN; Serum creatinine ≤1.5 × ULN. 6:Presence of at least one measurable target lesion according to RECIST version 1.1.
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  • 7::Female participants must use effective contraceptive measures during the study period and for 6 months after completion of the study. Male participants must agree to use effective contraceptive measures during the study period and for 6 months after completion of the study.
  • 8:Ability to understand the study procedures, voluntarily sign the informed consent form (ICF), and demonstrate good compliance with study requirements.
  • 9:Baseline assessment established based on ^18F-FDG PET/CT findings. Exclusion Criteria
  • Presence of any of the following conditions: brain metastases, except asymptomatic primary or metastatic brain tumors that do not require treatment; carcinomatous meningitis; myocardial infarction within 6 months prior to enrollment; unstable angina; high risk of uncontrolled arrhythmia; history of coronary artery bypass grafting; cerebrovascular accident within 6 months prior to enrollment; congestive heart failure (NYHA Class III-IV); pulmonary embolism; deep vein thrombosis; concurrent infection requiring intravenous antibiotic treatment within the previous 2 weeks; or receipt of immunosuppressive therapy following organ transplantation.
  • Primary central nervous system tumors.
  • HBV DNA ≥10⁴ copies/mL or ≥2,000 IU/mL.
  • HCV RNA ≥1,000 copies/mL.
  • Positive HIV antibody or syphilis antibody test.
  • History of acute or subacute intestinal obstruction or inflammatory bowel disease.
  • Pregnancy, breastfeeding, or plans to become pregnant during the study period.
  • Known allergy to the investigational drug or any of its excipients.
  • History of substance abuse involving psychiatric medications that cannot be discontinued, or presence of a psychiatric disorder.
  • Inability to lie flat for at least 30 minutes.
  • Known allergy to any component of the imaging agents or antibodies used in the study.
  • Inability to undergo PET/CT imaging.
  • Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ethics Committee of Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

This prospective, single-center, open-label study aims to evaluate the safety, biodistribution, and tumor imaging characteristics of the novel ACE1-targeted PET radiotracer 68Ga-DOTA-BPP in patients with confirmed or suspected triple-negative breast cancer (TNBC). Participants will undergo ^68Ga-DOTA-BPP PET/CT and 18F-FDG PET/CT. Visual and semiquantitative imaging analyses will be performed to assess tracer uptake in tumor lesions and normal organs. The relationship between ^68Ga-DOTA-BPP uptake and ACE1 expression will also be explored in participants with available tumor tissue.

Read the detailed description

Angiotensin-converting enzyme 1 (ACE1) has been reported to be aberrantly expressed in triple-negative breast cancer (TNBC) and may represent a potential molecular imaging target. BPP is an ACE1-targeting peptide, and our group has developed 68Ga-DOTA-BPP as a novel PET radiotracer for noninvasive visualization of ACE1 expression in vivo.

This first-in-human study is designed to evaluate the safety, biodistribution, and tumor imaging characteristics of 68Ga-DOTA-BPP PET/CT in patients with confirmed or suspected TNBC. Participants will undergo 68Ga-DOTA-BPP PET/CT as well as 18F-FDG PET/CT. Visual and semiquantitative analyses will be used to characterize tracer uptake in tumor lesions and normal organs. In participants with available tumor tissue, the relationship between 68Ga-DOTA-BPP uptake and ACE1 expression assessed by immunohistochemistry will also be explored.

The study is expected to provide preliminary clinical evidence regarding the feasibility of ACE1-targeted PET imaging for the noninvasive characterization of TNBC lesions and to support further clinical development of 68Ga-DOTA-BPP.

Conditions
Cancer
Being tested
68Ga-DOTA-BPP, 18F-FDG
Keywords
PET/CT, TNBC, 68Ga labeling, diagnosis
Medical subject headings
Neoplasms, Disease

What participants receive

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

  • 68Ga-DOTA-BPPDrug

    68Ga-DOTA-BPP is an ACE1-targeted PET radiotracer. After intravenous administration of 3-5 mCi of quality-controlled 68Ga-DOTA-BPP, PET/CT imaging will be performed to evaluate the safety, biodistribution, and tumor imaging characteristics of the tracer in patients with confirmed or suspected triple-negative breast cancer.

  • 18F-FDGDrug

    Participants will receive an intravenous injection of 18F-FDG at 0.1-0.15 mCi/kg after fasting for at least 6 hours. Whole-body PET/CT imaging will be performed approximately 1 hour after injection.

Study groups in NCT06203119
Study groupRoleWhat they receive
68Ga-DOTA-BPP PET/CTExperimentalParticipants assigned to this single arm will undergo both 18F-FDG PET/CT and 68Ga-DOTA-BPP PET/CT. 18F-FDG PET/CT will be performed as the conventional imaging examination for within-participant comparison. 68Ga-DOTA-BPP PET/CT will be performed to evaluate the safety, biodistribution, and tumor imaging characteristics of this novel ACE1-targeted radiotracer in patients with confirmed or suspected triple-negative breast cancer (TNBC). Visual and semiquantitative analyses will be used to assess radiotracer uptake in tumor lesions and normal organs.
Receives: Drug: 68Ga-DOTA-BPP; Drug: 18F-FDG

What is being measured

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

  1. Safety and tolerability of 68Ga-DOTA-BPP

    Incidence and severity of adverse events following intravenous administration of68Ga-DOTA-BPP, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

    Measured: From 68Ga-DOTA-BPP administration through completion of the PET/CT imaging procedures on the same day

  2. Biodistribution of 68Ga-DOTA-BPP in normal organs

    Visual and semiquantitative PET/CT assessment of 68Ga-DOTA-BPP uptake and distribution in normal organs at the prespecified imaging time points.

    Measured: Within 2 hours after 68Ga-DOTA-BPP administration.

Secondary outcomes (2)

  1. Detection of TNBC lesions by 68Ga-DOTA-BPP PET/CT

    The detection rate of target lesions by 68Ga-DOTA-BPP PET/CT will be assessed using visual and semiquantitative image analysis.

    Measured: Within 2 hours after 68Ga-DOTA-BPP administration

  2. Association between 68Ga-DOTA-BPP uptake and ACE1 expression

    The relationship between tumor uptake of 68Ga-DOTA-BPP, including SUVmax, and ACE1 expression assessed by immunohistochemistry (e.g., H-score or IRS) will be evaluated in participants with available tumor tissue.

    Measured: Up to 2 months after PET/CT imaging

Timeline

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

  1. First posted12 Jan 2024
  2. Study start6 Mar 2024
  3. Primary completion18 Dec 2025
  4. Study completion18 Dec 2025

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
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06203119
Sponsor's protocol ID
2023KT160
Status last verified
Sep 2026
First submitted
2 Jan 2024
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 68Ga-DOTA-BPP and 18F-FDG in people with Cancer, run by Peking University Cancer Hospital & Institute 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 22 inclusion and 0 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 30 Sep 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 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.

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

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?

Safety and tolerability of 68Ga-DOTA-BPP (time frame: From 68Ga-DOTA-BPP administration through completion of the PET/CT imaging procedures on the same day). The study lists 2 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 NCT06203119.

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 30 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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