NCT04801264

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2020

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

February 23, 2021

Last Update Submit

March 18, 2021

Conditions

Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Diagnostic value

    Sensitivity and Specificity of 68Ga-PSMA PET/CT for adenoid cystic carcinoma in comparison with 18F-FDG PET/CT

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Safety of therapy

    through study completion, an average of 1 year

Other Outcomes (2)

  • Therapeutic effect

    through study completion, an average of 1 year

  • Correlation between PSMA expression and SUV in PET/CT

    through study completion, an average of 1 year

Study Arms (1)

68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy

EXPERIMENTAL

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-PSMADrug: 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617

Interventions

68Ga-PSMADRUG

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.

Also known as: 68Ga-prostate specific membrane antigen
68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy
1.85GBq (50 mCi) of 177Lu-EB-PSMA-617DRUG

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.

68Ga-PSMA, PET/CT and 177Lu-EB-PSMA-617 therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed treated or untreated adenoid cystic carcinoma patients;
  • F-FDG PET/CT within two weeks;
  • signed written consent.

You may not qualify if:

  • pregnancy;
  • breastfeeding;
  • known allergy against PSMA
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (1)

  • Wang G, Zhou M, Zang J, Jiang Y, Chen X, Zhu Z, Chen X. A pilot study of 68 Ga-PSMA-617 PET/CT imaging and 177Lu-EB-PSMA-617 radioligand therapy in patients with adenoid cystic carcinoma. EJNMMI Res. 2022 Aug 19;12(1):52. doi: 10.1186/s13550-022-00922-x.

    PMID: 35984529DERIVED

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

gallium 68 PSMA-11177Lu-EB-PSMA-617

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhaohui Zhu, MD

CONTACT

86-1361109375213611093752@163.com

Guochang Wang, MD

CONTACT

86-18516822732guochang1007@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 16, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

December 31, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations

CN(1)