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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Precise Guidance of Adaptive Radiotherapy for Nasopharyngeal Carcinomar

NCT07137052

Nasopharyngeal Carcinoma (NPC) PET / CT

NOT_YET_RECRUITING

68Ga-FAPI-46 PET/CT for the Prediction of Clinical Response to Neoadjuvant Therapy in Nasopharyngeal Carcinoma Patients

NCT07139054

Nasopharyngeal Cancer

COMPLETED

Paclitaxel (Albumin-bound) Combined With Radiotherapy for the Treatment of Early Stage Nasopharyngeal Carcinoma

NCT04766359

Nasopharyngeal Carcinoma

UNKNOWN PHASE3

NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma

NCT06167109

Nasopharyngeal Carcinoma by AJCC V8 Stage

RECRUITING NA

The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma

NCT04769076

Nasopharyngeal Carcinoma

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adenoid Cystic Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

68Ga-PSMA

Intervention Type DRUG

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.

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

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-prostate specific membrane antigen

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No