18F-FDG versus 68Ga-FAPI-46 as PET tracer in ER-positive breast cancer - a pilot study

2023-508066-15-00 Therapeutic exploratory (Phase II) Not authorised

Status Not authorised · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Not authorised
Participants planned 10
Countries 1
Sites 1

Hormone-positive breast cancer

The aim of this pilot study is to investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a PET tracer in patients with ER+ breast cancer.

Key facts

Sponsor
University Hospital Maastricht
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
Decision date (initial)
2024-07-08
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

External identifiers

EU CT number
2023-508066-15-00
ClinicalTrials.gov
NCT06335069

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Others, Efficacy

The aim of this pilot study is to investigate the accuracy of 68Ga-FAPI-46 compared to 18F-FDG as a PET tracer in patients with ER+ breast cancer.

Secondary objectives 1

  1. To investigate the differences between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI.

Conditions and MedDRA coding

Hormone-positive breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Female patient with histopathologically proven ER+ breast cancer.
  2. Diagnosed with locally advanced (primary tumor >5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
  3. Willing and able to undergo the study procedures.
  4. Has personally provided written informed consent.

Exclusion criteria 8

  1. Age <18.
  2. Pregnancy.
  3. Patients with secondary malignancies.
  4. No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
  5. Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
  6. Inability to provide informed consent.
  7. Chronic inflammatory disease such as rheumatoid arthritis.
  8. Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. To investigate the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET.

Secondary endpoints 1

  1. To investigate the number of lesions detected on 68Ga-FAPI-46 PET/CT but not on 68Ga-FAPI-46 PET/MRI and vice versa.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

68Ga-FAPI-46

PRD11117979 · Product

Active substance
(S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS BOLUS USE
Max daily dose
3 MBq/kg megabecquerel(s)/kilogram
Max total dose
495 MBq megabecquerel(s)
Max treatment duration
1 Day(s)
Authorisation status
Not Authorised
MA holder
UNIVERSITY HOSPITAL MAASTRICHT
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Hospital Maastricht

9 Total trials 4 Recruiting 4 Ended
Academic / Non-commercial
Sponsor organisation
University Hospital Maastricht
Address
P Debyelaan 25
City
Maastricht
Postcode
6229 HX
Country
Netherlands

Scientific contact point

Organisation
University Hospital Maastricht
Contact name
T.J.A. van Nijnatten

Public contact point

Organisation
University Hospital Maastricht
Contact name
T.J.A. van Nijnatten

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Netherlands Not authorised 10 1
Rest of world — 0 —

Investigational sites

Netherlands

1 site · Not authorised
Maastricht University Medical Center
Radiology and Nuclear Medicine, P Debyelaan 25, 6229HX, Maastricht

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-03-28 Netherlands Not acceptable
2024-07-08
 2024-07-08

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