PSMA-PET Imaging for Advanced ACC/SDC | NCT03319641

Studies
PSMA-PET Imaging for Advanced ACC/SDC

NCT03319641

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

May 30, 2018Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Salivary Gland Cancer
Adenoid Cystic Carcinoma
Salivary Duct Carcinoma

Interventions

PSMA-PET/CT scan

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2017Actual

Primary Completion Date

May 14, 2018Actual

Completion Date

May 14, 2018Actual

First Submitted Date

Sep 29, 2017

First Submission Date that Met QC Criteria

Oct 19, 2017

First Posted Date

Oct 24, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2018

Last Update Posted Date

May 30, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carla van Herpen, MD, PhD, Radboud University Medical CenterPrincipal Investigator

Lead Sponsor

Radboud University Medical CenterOTHER

Collaborators

Name	Class
Adenoid Cystic Carcinoma Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Diagnostic study which evaluates the level of PSMA expression in patients with locally advanced, recurrent and/or metastatic ACC/SDC of ≥18 years old with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy

Detailed Description

Rationale: PSMA is a transmembrane protein, which is expressed on prostate cancers cells, ACC and other malignancies. In prostate cancer, distant metastases can be visualized sensitively and non-invasively with 68Ga-PSMA-PET/CT scans and if the uptake of 68Ga is high enough, patients can be treated with the β-emitting radionuclide 177Lu-PSMA. In the current study, we will evaluate the uptake of 68Ga-PSMA by performing 68Ga-PSMA-PET/CT scans in advanced ACC and SDC patients. If the uptake is high enough, this will form the rationale for a therapeutic study with 177Lu-PSMA in ACC and SDC.

Objective: The primary objective is to evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans. The secondary objectives are to calculate the SUV tumor-to-background ratio and tumor-to-'healthy salivary gland tissue' ratio. To correlate the SUV to the degree of immunohistochemical PSMA expression of the primary tumor on archival tissue, and to establish whether new metastatic lesions are found by 68GA-PSMA-PET/CT imaging.

Study design: Diagnostic study which evaluates the level of PSMA expression in ACC/SDC patients with 68Ga-PSMA-PET/CT imaging in order to establish whether these patients are eligible for 177Lu-PSMA therapy.

Study population: Patients with locally advanced, recurrent or metastatic ACC/SDC of ≥18 years old.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSMA-PET/CT scan	Experimental	PSMA-PET/CT imaging in advanced ACC/SDC	Diagnostic Test: PSMA-PET/CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PSMA-PET/CT scan	Diagnostic Test	perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC	PSMA-PET/CT scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
uptake of 68Ga-PSMA in ACC and SDC	To evaluate the uptake of 68Ga-PSMA in locally advanced, recurrent and metastatic ACC/SDC by performing 68Ga-PSMA-PET/CT scans	0 days

Secondary Outcomes

Measure	Description	Time Frame
SUV of 68Ga-PSMA in ACC/SDC tumors	SUV of 68Ga-PSMA in ACC/SDC tumors	0 days
SUV of 68Ga-PSMA in the background	in order to calculate the SUV tumor to background ratio

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

locally advanced, recurrent or metastatic ACC/SDC
Age ≥ 18 years old
Ability to provide written informed consent

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carla ML van Herpen, MD, PhD	Radboud University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboudumc		Nijmegen	Gelderland	6500HB	Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 17, 2017	Oct 9, 2017	Prot_SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D012468	Salivary Gland Neoplasms
D003528	Carcinoma, Adenoid Cystic

Ancestor Terms

ID	Term
D009062	Mouth Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided