Breast Carcinoma Clinical Trial
Official title:
Phase 1 Study of 18F-Al-NOTA-PRGD2 in Cancer Diagnostics
The purpose of this study is to determine whether 18F-Al labeled RGD is safety and effective for cancer diagnosis and therapy response.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Volunteers or patients with age more than 18 yeas; 2. The patients have been diagnosed with cancer or suspected with cancer; 3. It must fulfill the ethical requirements and subjects have signed an informed consent. Exclusion Criteria: 1. Pregnancy or nursing mothers; 2. Having drugs or alcohol dependence; 3. Hypersensitive to the active or inactive ingredients of the study drug; 4. Having attended other drug clinical trials within three months; 5. Cardiac functional insufficiency; 6. Hepatic and renal function insufficiency; 7. Hypertensive patients with serious complications; 8. Endangering the safety of life. |
Country | Name | City | State |
---|---|---|---|
China | Wuxi No. 4 People's Hospital | Wuxi | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Wuxi No. 4 People's Hospital |
China,
Beer AJ, Haubner R, Sarbia M, Goebel M, Luderschmidt S, Grosu AL, Schnell O, Niemeyer M, Kessler H, Wester HJ, Weber WA, Schwaiger M. Positron emission tomography using [18F]Galacto-RGD identifies the level of integrin alpha(v)beta3 expression in man. Cli — View Citation
Beer AJ, Lorenzen S, Metz S, Herrmann K, Watzlowik P, Wester HJ, Peschel C, Lordick F, Schwaiger M. Comparison of integrin alphaVbeta3 expression and glucose metabolism in primary and metastatic lesions in cancer patients: a PET study using 18F-galacto-RG — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety data included vital signs (blood pressure, respiratory rate, heart rate, and body temperature) (composite) | Safety data were collected before and after injection of 18F-Al-NOTA-PRGD2. physical examination; ECG; laboratory parameters (blood routine, liver function and kidney function) and adverse events. | 1 day | |
Secondary | radioactive distribution of normal organ, standard uptake value of tumor | Visual analysis whole body 18F-Al-NOTA-PRGD2 PET;Regions of interest (ROIs) were drawn manually on each image with the assistance of corresponding CT images. The results were expressed as standardized uptake value (SUV). | 60 minutes | |
Secondary | Diagnostic performance analysis to assess "sensitivity,specificity,accuracy,etc" | compare the Diagnostic outcome to pathology or clinic follow-up,then to gather statistics of sensitivity,specificity,accuracy,etc. | 1 day-1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04996316 -
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals
|
||
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Completed |
NCT05526872 -
A Patient Reminder and Self-Referral Via Online Patient Portals and Text Messaging to Improve Adherence to Breast Cancer Screening
|
N/A | |
Not yet recruiting |
NCT05178498 -
Impact of Dietary Inflammatory Potential on Breast Cancer Risk
|
||
Recruiting |
NCT05544123 -
The Treatment Situation of Chinese County Population With Breast Cancer
|
||
Withdrawn |
NCT05191004 -
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
|
Phase 1/Phase 2 | |
Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
Recruiting |
NCT01462903 -
A Study of Adoptive Immunotherapy With Autologous Tumor Infiltrating Lymphocytes in Solid Tumors
|
Phase 1 | |
Completed |
NCT01422408 -
Fluocinonide Cream in Treating Symptoms of Vaginal Dryness and Painful Sexual Intercourse In Patients With Breast Cancer Undergoing Hormone Therapy
|
Phase 2 | |
Terminated |
NCT02810873 -
Positron Emission Tomography Imaging Using Copper Cu 64 TP3805 in Patients With Breast Cancer
|
N/A | |
Terminated |
NCT00770354 -
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
|
Phase 2 | |
Withdrawn |
NCT03185871 -
Celecoxib Window of Opportunity Trial to Assess Tumor and Stroma Responses
|
Phase 2 | |
Completed |
NCT02983279 -
Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer
|
N/A | |
Active, not recruiting |
NCT02194387 -
Energy Balance Interventions in Increasing Physical Activity in Breast Cancer Gene Positive Patients, Lynch Syndrome-Positive Patients, CLL Survivors or High-Risk Family Members
|
N/A | |
Recruiting |
NCT05406232 -
Temporal Immunologic Changes With Hypofractionated Radiation-Induced DNA Damage in Breast Cancer
|
||
Recruiting |
NCT03408353 -
Mammography, Early Detection Biomarkers, Risk Assessment, and Imaging Technologies, MERIT Study
|
||
Completed |
NCT01641068 -
Memory and Thinking Skills Workshop to Improve Cognition in Gynecologic and Breast Cancer Survivors With Cognitive Symptoms
|
N/A | |
Withdrawn |
NCT04190433 -
Autophagy Activation for the Alleviation of Cardiomyopathy Symptoms After Anthracycline Treatment, ATACAR Trial
|
Phase 2 | |
Recruiting |
NCT04799535 -
Quantitative Microvasculature Imaging for Breast Cancer Detection and Monitoring
|
||
Terminated |
NCT02923037 -
Hatha Yoga in Breast Cancer Survivors
|
N/A |