PSMA-PET scan for incurable or metastatic salivary gland cancer

68Ga-PSMA-PET/CT imaging for locally advanced, recurrent and metastatic adenoid cystic carcinoma or salivary duct carcinoma - PSMA-PET imaging for advanced ACC/SDC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002093-40-NL

Enrollment

Registered

2017-06-08

Start date

2017-08-30

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma or salivary duct carcinoma

Interventions

Product Name: Gallium-68-PSMA-HBED-CC Product Code: PSMA-11 Pharmaceutical Form: Radionuclide generator INN or Proposed INN: 68Ga-PSMA-HBED-cc Other descriptive name: GALLIUM(68GA)-(HBED-CC)-(AHX)LYS-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: •locally advanced, recurrent or metastatic ACC/SDC •Age = 18 years old •Ability to provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: •Contra-indication for PET imaging (pregnancy, breast feeding, severe claustrophobia) •Impaired renal function: MDRD <30 ml/min/1,73 m2 •Impaired liver function: AST and ALT = 2.5 x ULN (=5 x ULN for patients with liver metastases)

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans;Secondary Objective: •To calculate the SUV tumor-to-background ratio and tumor-to-‘healthy salivary gland tissue’ ratio. •Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue. •To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging. ;Primary end point(s): the uptake of 68Ga-PSMA, quantified with the SUV.;Timepoint(s) of evaluation of this end point: 1 PSMA-PET/CT scan will be made in every participant. All analysis can be done directly afterwards. No follow-up is needed.	—

Measure

Time frame

Main Objective: To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans;Secondary Objective: •To calculate the SUV tumor-to-background ratio and tumor-to-‘healthy salivary gland tissue’ ratio. •Correlate the tumor uptake (SUV) to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue. •To establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging. ;Primary end point(s): the uptake of 68Ga-PSMA, quantified with the SUV.;Timepoint(s) of evaluation of this end point: 1 PSMA-PET/CT scan will be made in every participant. All analysis can be done directly afterwards. No follow-up is needed.

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Secondary

Measure	Time frame
Secondary end point(s): - the uptake of 68Ga-PSMA in other tissues - the level of immunohistochemical PSMA staining - the detection of new metastatic lesions with PSMA-PET.;Timepoint(s) of evaluation of this end point: all analysis can be done without follow-up.	—

Countries

Netherlands

Contacts

Public ContactCarla M.L. van Herpen

Radboudumc

carla.vanherpen@radboudumc.nl+310243667251

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026