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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 68Ga-PSMA
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety of therapy [ Time Frame: through study completion, an average of 1 year ]
    the safety assessed by CTCAE v4.0


Other Outcome Measures:
  1. 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.

  2. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Zhaohui Zhu, MD 86-13611093752 13611093752@163.com
Contact: Guochang Wang, MD 86-18516822732 guochang1007@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Zhaohui Zhu, MD    86-13611093752    13611093752@163.com   
Contact: Guochang Wang, MD    86-18516822732    guochang1007@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Zhaohui Zhu, MD Peking Union Medical College Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04801264    
Other Study ID Numbers: PekingUMCHPSMAACC
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Adenocarcinoma
Gallium 68 PSMA-11
177Lu-EB-PSMA-617
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action