Screening for occult malignancy using 18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT) in patients with unprovoked venous thromboembolism

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

8 Sep 2020 → ongoing

Decision date (initial)

2024-06-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514703-34-00

EudraCT number

2020-002210-41

ClinicalTrials.gov

NCT04304651

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To determine whether adding a FDG-PET/CT to a limited screening strategy misses less cancer than a limited cancer screening strategy alone in patients aged 50 years or older with a first unprovoked VTE over a 1-year follow-up period.

Secondary objectives 6

1. 1) To compare the proportion of patients receiving a cancer diagnosis at the initial allocated screening strategy.
2. 2) To assess whether the extensive screening strategy including FDG PET/ CT enables the diagnosis of more early-stage cancers than the limited screening strategy.
3. 3) To find out if the patients diagnosed with cancer are still alive after five years (i.e. the patients with curable cancer were treated and are doing well).
4. 4) To assess the cost and the effectiveness (cancers detected) of adding FDG-PET/CT to limited screening in patients with unprovoked VTE.
5. 5) To compare the frequency of patients receiving additional tests following each strategy at screening and during follow-up.
6. 6) To develop a decision aid to assist patients in the decision of cancer screening.

Conditions and MedDRA coding

Thromboembolic event

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients aged 50 years or older with a new diagnosis of first unprovoked proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) ≤ 4 weeks as detailed below will be eligible to participate into the study.
2. No recent paralysis, paresis, or prolonged immobilization> 3 days for acute medical condition or plaster cast of the lower limbs in the last 3 months.
3. No major surgery (within the past 3 months) requiring general or regional anaesthesia
4. No biological or clinical thrombophilia
5. No active malignancy (known malignancy, progressive and/or treated during the last 5 years) except for adequately treated basal or squamous cell carcinoma. Patients whose state of health suggests the presence of cancer at the time of diagnosis of VTE cannot be included in the protocol.

Exclusion criteria 8

1. Hypersensitivity to 18F-FDG or any of the excipients according to the product monograph
2. Unavailable to follow-up
3. VTE while on anticoagulation (e.g apixaban, rivaroxaban, edoxaban, dabigatran, warfarin)
4. VTE provoked by a major inherited or acquired risk factor
5. Refusal or inability to provide informed consent
6. Life expectancy <12 months
7. Ongoing pregnancy
8. Vulnerable individuals (Persons deprived of their liberty by judicial or administrative decision; Persons under psychiatric care under duress; Persons admitted to a health or social institution for purposes other than research; Persons of full age subject to a legal protection measure; persons under protective custody)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Occult cancer “missed” by cancer screening defined as proven cancer diagnosed (either biopsy proven cancer or cancer diagnosis approved by adjudication committee in the absence of biopsy proven cancer) from the time of cancer screening completion to the end of the 1-year follow-up period, and not detected at the time of screening.

Secondary endpoints 6

1. 1) New cancer diagnosis after completion of the initial allocated screening strategy.
2. 2) Early-stage (T1-2N0M0 as per the World Health Organization TNM classification system) and advanced-stage tumors at initial screening and during follow-up.
3. 3) Cancer-related mortality during a 5-year follow-up period.
4. 4) Diagnosis of cancer and costs from the viewpoint of the healthcare system over a one-year period in order to estimate the additional cost per additional cancer detected and the incremental cost utility ratio
5. 5) Additional tests following each strategy and during follow-up.
6. 6) The data of this study will be used to develop a decision aid to assist future patients in the decision of cancer screening

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Et Universitaire De Brest

Sponsor organisation

Centre Hospitalier Regional Et Universitaire De Brest

Address

2 Avenue Marechal Foch

City

Brest

Postcode

29200

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Clinical trial manager

Public contact point

Organisation

Centre Hospitalier Regional Et Universitaire De Brest

Contact name

Clinical trial manager

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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