PET-DOPA Metabolic Detection and Characterization of Untreated Brain Metastases of Bronchial, Breast and Melanoma Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Institut De Cancerologie De L Ouest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Dec 2021 → 3 Dec 2025

Decision date (initial)

2024-07-04

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ICO funding · CURIUM France

External identifiers

EU CT number

2024-515850-26-00

EudraCT number

2021-001017-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To define the sensitivity of PET-DOPA for the detection of newly diagnosed untreated brain metastases (breast, lung, melanoma) on MRI measuring at least 5 mm in diameter

Secondary objectives 4

1. a) Define the sensitivity of DOPA-PET according to the site of the primary tumor (lung, breast, melanoma) and its characteristics
2. b) Characterize DOPA+ lesions in 20 and 30 minutes summed images analysis (SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio)
3. c) Characterize DOPA+ lesions by dynamic image analysis (activity-time curves)
4. d) For lesions operated within 2 months after the realization of the PETDOPA, to evaluate the correlation between the various parameters of characterization of the F-DOPA fixation and the characteristics of the MC

Conditions and MedDRA coding

patients with newly discovered brain metastases (non-small cell lung cancer, breast cancer or melanoma) measuring more than 5 mm and explored on MRI

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Histologically proven primary cancer (non-small cell lung, breast or melanoma)
2. 2) Presence of brain metastasis(s) visualized on MRI, with at least 1 measuring more than 5 mm
3. 3) Age ≥ 18 years

Exclusion criteria 6

1. 1) History of cerebral irradiation
2. 2) Previous brain surgery for brain metastasis or glial tumor
3. 3) Systemic therapy (chemotherapy, targeted therapy, immunotherapy) modified in the 6 weeks preceding the PET-DOPA scan,
4. 4) New anti-tumor treatment (excluding corticosteroids) started between the discovery of CD and the performance of the PET-DOPA scan
5. 5) Other concomitant cancer, or history of cancer in the 5 years preceding the patient's inclusion in the protocol other than basal or squamous cell carcinoma
6. 6) Pregnant, likely to be pregnant or breastfeeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. number of metastases detected on PET-DOPA compared to the number of metastases + 5 mm detected on MRI

Secondary endpoints 4

1. a) The sensitivity of DOPA-PET is defined above (primary endpoint). Site-specific sensitivity will be calculated for 8 primary tumor categories: 3 for lung cancer (EGFR mutation or ALK rearrangement; PDL1+; others), 2 for melanoma (BRAF V600 mutation; others), 3 for breast cancer (triple negative; Her2+ RH-; others)
2. b) Lesion characterization will be defined by SUVmax, SUVmean, tumor/brain background fixation ratio, tumor/striatum fixation ratio.
3. c) Dynamic images are described with the analysis of activity-time curves (time to peak, slope of the curve from the 10th minute).
4. d) The 8 categories mentioned above will be considered for the classification of the operated MC

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Institut De Cancerologie De L Ouest

Sponsor organisation

Institut De Cancerologie De L Ouest

Address

15 Rue Andre Boquel

City

Angers

Postcode

49100

Country

France

Scientific contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

MOREL Olivier

Public contact point

Organisation

Institut De Cancerologie De L Ouest

Contact name

TIGREAT Marine

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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