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Trial Title:
68Ga-HER2 Affibody PET/CT Imaging for HER2-Positive Cancer Patients
NCT ID:
NCT05535621
Condition:
HER2-Positive Cancer
Conditions: Keywords:
HER2
PET
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
The prevalence of HER2 alterations in pan-cancer indicates a broader range of application
of HER2-targeted therapies. immunohistochemistry (IHC) or amplification by fluorescence
in situ hybridization (FISH) is currently the most commonly used method for evaluation of
HER-2 status in cancer patients. However, biopsies are spatiotemporally limited because
of the highly heterogeneous expression of HER2. Patients with false-negative HER2 results
may miss the chance for targeted therapy. Additionally, the HER2 status can change during
the disease process.
A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors.
Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2
positive breast cancer and gastric cancer without any observed toxicity. However, studies
are still insufficient and limited to breast cancer and gastric cancer.
The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively
assess HER2 status in metastatic or recurrent solid tumors including breast cancer,
gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and
uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2
positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET
will be determined.
Detailed description:
The prevalence of HER2 alterations in pan-cancer indicates a broader range of application
of HER2-targeted therapies. Tumors including breast cancer, gastrointestinal tumors, head
and neck squamous tumors, bladder cancer, lung cancer and uterine tumors exhibited high
HER2 indices together with HER2 amplification or overexpression, which may benefit from
HER2-targeted therapies.
immunohistochemistry (IHC) or amplification by fluorescence in situ hybridization (FISH)
is currently the most commonly used method for evaluation of HER-2 status in cancer
patients. However, biopsies are spatiotemporally limited because of the highly
heterogeneous expression of HER2. Patients with false-negative HER2 results may miss the
chance for targeted therapy. Additionally, the HER2 status can change during the disease
process.
A investigational imaging tracer named 68Ga-HER2 Affibody binds to HER-2 receptors.
Previous studies in human have shown the efficacy of 68Ga-HER2 Affibody in detecting HER2
positive breast cancer and gastric cancer without any observed toxicity. However, studies
are still insufficient and limited to breast cancer and gastric cancer.
The investigators hypothesized that 68Ga-HER2 Affibody PET imaging can noninvasively
assess HER2 status in metastatic or recurrent solid tumors including breast cancer,
gastrointestinal tumors, head and neck squamous tumors, bladder cancer, lung cancer and
uterine tumors lesion. In this study, efficacy of 68Ga-HER2 Affibody in detecting HER2
positive cancer lesions and change of patient management based on 68Ga-HER2 Affibody PET
will be determined.
Criteria for eligibility:
Study pop:
patients with HER2-Positive tumor
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
patients with clinically diagnosed HER2-Positive tumor subjects need to sign the informed
consent
Exclusion Criteria:
- Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
TongjiHospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Recruiting
Contact:
Last name:
xiaohua zhu, Dr.
Start date:
December 18, 2021
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Tongji Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05535621
