Diagnosis of Adenoid Cystic Carcinoma on 68Ga-PSMA-617 PET-CT and Therapy With 177Lu-EB-PSMA-617

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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