HER2 Positive or Suspicious Positive TumorsNCT04547309
Research for the Molecular Imaging of the HER2 Targeting Tracer
A study testing 68Ga/18F-HER2 Affibody PET/CT scan in people with HER2 Positive or Suspicious Positive Tumors, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2 Positive or Suspicious Positive Tumors
- What is being tested?
- 68Ga/18F-HER2 Affibody PET/CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2020to 30 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 18 years old; ECOG 0 or 1;
- Patients with HER2 positive or suspicious positive tumors;
- Has at least one measurable target lesion according to CT or MRI;
- Life expectancy ≥ 12 weeks.
Who cannot join
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
- Any other situation that researchers considered it unsuitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hua Zhu
Beijing, Beijing Municipality, 100142
Shunlian Zhou, 010-88196391, zhoushunlian@163.com
About this study
To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of HER2 expression in the course of treatment. To provide an approach for screening patients high expression of HER2, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.
Read the detailed description
HER2 is an important biomarker and directly influences the treatment effect. The guidelines indicate that only HER2-positive patients are eligible for trastuzumab therapy.HER2 positivity is defined as a HER2 score of 3+ by IHC or FISH. However, gastroscopic biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. And this procedure is invasive and may substantially increase the incidence of side effects. Additionally, patients with false-negative HER2 results miss the chance for targeted therapy. Moreover, HER2 status can change during the disease process.Thus, a noninvasive, whole-body, HER2-targeted imaging method may be valuable for choosing patients suitable for anti-HER2 therapy and monitoring the therapeutic efficacy. Direct labeling of HER2 antibodies with radionuclides allows clinicians to monitor HER2-targeted therapy and assists in patient staging. With the feasibility of a long half-life and decay time, positron emission tomography (PET) nuclides, such as 64Cu (T1/2= 12.7 h) and 89Zr (T1/2= 78.4 h), can label trastuzumab for the clinical PET imaging of HER2 in GC and breast cancer. Because of the long half-life of 89Zr, 89Zr-trastuzumab is estimated to produce a dosimetry exposure of 0.5 mSv/MBq (compared with the 0.019 mSv/MBq of 18FDG) in patients. Additionally, imaging needs to be performed several days after injection due to the slow blood clearance of antibodies.
In this study, 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT imaging will be performed in patients with HER2-positive tumors to access the potential of 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT to screen patients who can benefit from HER2 target treatment.
- Being tested
- 68Ga/18F-HER2 Affibody PET/CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga/18F-HER2 Affibody PET/CT scanRadiation
HER2 Affibody, labeled with PET radio-nuclide ( 68Ga or F-18) will be used as a molecular imaging tracer for PET/CT scan. All participants will undergo 68Ga/18F-HER2 Affibody PET/CT scan.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga/18F-HER2 Affibody PET/CT scan | Experimental | Not described Receives: Radiation: 68Ga/18F-HER2 Affibody PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start7 Sep 2020
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive or Suspicious Positive TumorsStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, North Sichuan Medical College
- Responsible party
- Principal investigator, Hua Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547309
- Sponsor's protocol ID
- 2018KT61/2019KT114
- Status last verified
- Aug 2024
- First submitted
- 7 Sep 2020
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo X, Liu J, Ma H, Ma X, Liang X, Zhu H, Li C, Yang Z, Zhou N. Al 18 F-NOTA-HER2-BCH Versus 18 F-FDG PET/CT for Detecting Bone Metastases : Sensitivity and Quantitative Comparison. Clin Nucl Med. 2026 Feb 1;51(2):123-131. doi: 10.1097/RLU.0000000000006249. Epub 2025 Dec 22.
PubMed 41474774Guo X, Liu J, Lin S, Gui X, Ding J, Liu T, Zhou N, Li S, Zhu H, Yang Z. Detectability of Al 18 F-NOTA-HER2-BCH PET for Nodal Metastases in Patients With HER2-Positive Breast Cancer. Clin Nucl Med. 2025 May 1;50(5):381-387. doi: 10.1097/RLU.0000000000005686. Epub 2025 Jan 24.
PubMed 39854676Gui X, Liang X, Guo X, Yang Z, Song G. Impact of HER2-targeted PET/CT imaging in patients with breast cancer and therapeutic response monitoring. Oncologist. 2025 Jan 17;30(1):oyae188. doi: 10.1093/oncolo/oyae188.
PubMed 39083323Guo X, Zhou N, Liu J, Ding J, Liu T, Song G, Zhu H, Yang Z. Comparison of an Affibody-based Molecular Probe and 18F-FDG for Detecting HER2-Positive Breast Cancer at PET/CT. Radiology. 2024 Jun;311(3):e232209. doi: 10.1148/radiol.232209.
PubMed 38888484
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for the Molecular Imaging of the HER2 Targeting Tracer
- ClinicalTrials.gov ID
- NCT04547309
- Acronym / sponsor ID
- 2018KT61/2019KT114
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, North Sichuan Medical College
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Sep 2020 (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.
To use the molecular PET radionuclide (Ga-68 or F-18) labelled HER2 Affibody to detect the expression of HER2 in the primary and metastatic lesions in patients with HER2 positive or suspicious positive tumors; to detect the expression heterogeneity of HER2 in the lesions and inter-lesions; to observe the change of HER2 expression in the course of treatment. To provide an approach for screening patients high expression of HER2, efficacy monitoring, drug resistance and early warning of recurrence and metastasis to achieve the individualized antitumor treatment of targeted drugs.
Detailed description
HER2 is an important biomarker and directly influences the treatment effect. The guidelines indicate that only HER2-positive patients are eligible for trastuzumab therapy.HER2 positivity is defined as a HER2 score of 3+ by IHC or FISH. However, gastroscopic biopsies are spatiotemporally limited because of the highly heterogeneous expression of HER2. And this procedure is invasive and may substantially increase the incidence of side effects. Additionally, patients with false-negative HER2 results miss the chance for targeted therapy. Moreover, HER2 status can change during the disease process.Thus, a noninvasive, whole-body, HER2-targeted imaging method may be valuable for choosing patients suitable for anti-HER2 therapy and monitoring the therapeutic efficacy. Direct labeling of HER2 antibodies with radionuclides allows clinicians to monitor HER2-targeted therapy and assists in patient staging. With the feasibility of a long half-life and decay time, positron emission tomography (PET) nuclides, such as 64Cu (T1/2= 12.7 h) and 89Zr (T1/2= 78.4 h), can label trastuzumab for the clinical PET imaging of HER2 in GC and breast cancer. Because of the long half-life of 89Zr, 89Zr-trastuzumab is estimated to produce a dosimetry exposure of 0.5 mSv/MBq (compared with the 0.019 mSv/MBq of 18FDG) in patients. Additionally, imaging needs to be performed several days after injection due to the slow blood clearance of antibodies.
In this study, 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT imaging will be performed in patients with HER2-positive tumors to access the potential of 68Ga-HER2 Affibody or 18F-HER2 Affibody PET/CT to screen patients who can benefit from HER2 target treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga/18F-HER2 Affibody PET/CT scan | Experimental | Radiation: 68Ga/18F-HER2 Affibody PET/CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged > 18 years old; ECOG 0 or 1;
- Patients with HER2 positive or suspicious positive tumors;
- Has at least one measurable target lesion according to CT or MRI;
- Life expectancy ≥ 12 weeks.
Key exclusion criteria (6 listed)
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
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 |
|---|---|---|
| 68Ga/18F-HER2 Affibody PET/CT scanHER2 Affibody, labeled with PET radio-nuclide ( 68Ga or F-18) will be used as a molecular imaging tracer for PET/CT scan. All participants will undergo 68Ga/18F-HER2 Affibody PET/CT scan. | Radiation | 68Ga/18F-HER2 Affibody PET/CT scan |
Primary outcome
SUV
Time frame: 3 years
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41474774Guo X, Liu J, Ma H, Ma X, Liang X, Zhu H, Li C, Yang Z, Zhou N. Al 18 F-NOTA-HER2-BCH Versus 18 F-FDG PET/CT for Detecting Bone Metastases : Sensitivity and Quantitative Comparison. Clin Nucl Med. 2026 Feb 1;51(2):123-131. doi: 10.1097/RLU.0000000000006249. Epub 2025 Dec 22.
- Derived from this study: PubMed 39854676Guo X, Liu J, Lin S, Gui X, Ding J, Liu T, Zhou N, Li S, Zhu H, Yang Z. Detectability of Al 18 F-NOTA-HER2-BCH PET for Nodal Metastases in Patients With HER2-Positive Breast Cancer. Clin Nucl Med. 2025 May 1;50(5):381-387. doi: 10.1097/RLU.0000000000005686. Epub 2025 Jan 24.
- Derived from this study: PubMed 39083323Gui X, Liang X, Guo X, Yang Z, Song G. Impact of HER2-targeted PET/CT imaging in patients with breast cancer and therapeutic response monitoring. Oncologist. 2025 Jan 17;30(1):oyae188. doi: 10.1093/oncolo/oyae188.
- Derived from this study: PubMed 38888484Guo X, Zhou N, Liu J, Ding J, Liu T, Song G, Zhu H, Yang Z. Comparison of an Affibody-based Molecular Probe and 18F-FDG for Detecting HER2-Positive Breast Cancer at PET/CT. Radiology. 2024 Jun;311(3):e232209. doi: 10.1148/radiol.232209.
- Individual participant dataSharing planned: No
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HER2 Positive or Suspicious Positive Tumors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga/18F-HER2 Affibody PET/CT scan in people with HER2 Positive or Suspicious Positive Tumors, 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 4 inclusion and 6 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 21 Mar 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV (time frame: 3 years). 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 NCT04547309, which also lists 4 linked publications.
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 21 Mar 2025.