Brief Title
Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617
Official Title
Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617
Brief Summary
Adenoid cystic carcinoma (ACC) accounts for 24% of salivary gland malignant tumors, is
characterized by frequent local recurrences and distant metastasis, mainly to lungs.
Considering its origination from salivary glands, an organ with intense physiological uptake
of 68Ga-PSMA-617, this study aims to evaluate 68Ga-PSMA-617 uptake in local recurrent or
metastatic ACC in comparison with 18F-FDG uptake in the same patients, and assess the
feasibility of 177Lu-EB-PSMA-617 treatment in patients with the advanced ACC.
Detailed Description
Adenoid cystic carcinoma (ACC) is a rare tumor entity with a yearly incidence of 3-5 cases
per million. ACC arises in the major salivary glands and more often in the minor salivary
glands of the oropharynx, lip, nasopharynx, oral cavity, nasal cavity, paranasal sinus,
larynx and tracheobronchial tree. ACC is characterized by frequent local recurrences and
distant metastasis, mainly to lungs. 18F-FDG PET/CT is considered to be a viable tool to
assess ACC at initial presentation. However, FDG uptake in ACC is lower than in squamous cell
carcinoma (SCC) and not all ACC lesions show detectable FDG uptake. So, it is necessary to
find another effective way to detect ACC and its metastases. As in known, PSMA is highly
expressed in salivary glands, and Wim van Boxtel et al had demonstrated high PSMA-ligand
uptake in a patient with recurrent and metastatic ACC using 68Ga-PSMA PET/CT. 68Ga-PSMA has
been developed as a targeting imaging agent widely used in prostate cancer in prostate
cancer. Thus, this prospective study is going to investigate whether 68Ga-PSMA PET/CT may be
superior for diagnosis, therapy response assessment and follow-up of ACC than 18F-FDG PET/CT.
Furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of
prostate cancer lesions that showed high PSMA uptake on 68Ga-PSMA PET/CT, we'll try to assess
the safety and therapeutic response to 177Lu-EB-PSMA-617 in patients with ACC.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Diagnostic value
Secondary Outcome
Safety of therapy
Condition
Adenoid Cystic Carcinoma
Intervention
68Ga-PSMA
Study Arms / Comparison Groups
68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 1, 2020
Completion Date
December 31, 2022
Primary Completion Date
September 1, 2022
Eligibility Criteria
Inclusion Criteria:
- confirmed treated or untreated adenoid cystic carcinoma patients;
- 18F-FDG PET/CT within two weeks;
- signed written consent.
Exclusion Criteria:
- pregnancy;
- breastfeeding;
- known allergy against PSMA
- any medical condition that in the opinion of the investigator may significantly
interfere with study compliance
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Zhaohui Zhu, MD, 86-13611093752, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04801264
Organization ID
PekingUMCHPSMAACC
Responsible Party
Sponsor
Study Sponsor
Peking Union Medical College Hospital
Study Sponsor
Zhaohui Zhu, MD, Principal Investigator, Peking Union Medical College Hospital
Verification Date
March 2021