Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617
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|ClinicalTrials.gov Identifier: NCT04801264|
Recruitment Status : Unknown
Verified March 2021 by Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : March 16, 2021
Last Update Posted : March 23, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: 68Ga-PSMA Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: 68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy
All patients diagnosed with ACC underwent 68Ga-PSMA PET/CT scan. If the PET/CT showed high PSMA expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 for therapy.
Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga-PSMA will be used to image lesions of adenoid cystic carcinoma by PET/CT.
Other Name: 68Ga-prostate specific membrane antigen
Drug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617
Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
- Diagnostic value [ Time Frame: through study completion, an average of 1 year ]Sensitivity and Specificity of 68Ga-PSMA PET/CT for adenoid cystic carcinoma in comparison with 18F-FDG PET/CT
- Safety of therapy [ Time Frame: through study completion, an average of 1 year ]the safety assessed by CTCAE v4.0
- Therapeutic effect [ Time Frame: through study completion, an average of 1 year ]the therapeutic response assessed by PSMA PET/CT to 177Lu-EB-PSMA-617 in patients with adenoid cystic carcinoma.
- Correlation between PSMA expression and SUV in PET/CT [ Time Frame: through study completion, an average of 1 year ]to mearsure the SUVmax of ACC on PSMA PET/CT and to investigate the expression of PSMA on primary, recurrent and metastatic ACC tumour tissue using immunohistochemistry, and analyze the correlation between them.
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- confirmed treated or untreated adenoid cystic carcinoma patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
- known allergy against PSMA
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04801264
|Contact: Zhaohui Zhu, MDfirstname.lastname@example.org|
|Contact: Guochang Wang, MDemail@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Zhaohui Zhu, MD 86-13611093752 firstname.lastname@example.org|
|Contact: Guochang Wang, MD 86-18516822732 email@example.com|
|Principal Investigator:||Zhaohui Zhu, MD||Peking Union Medical College Hospital|
|Responsible Party:||Peking Union Medical College Hospital|
|Other Study ID Numbers:||
|First Posted:||March 16, 2021 Key Record Dates|
|Last Update Posted:||March 23, 2021|
|Last Verified:||March 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gallium 68 PSMA-11
Molecular Mechanisms of Pharmacological Action