Clinical use of USPIO contrast media in the assessment of pelvic lymph node metastasis in rectal cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Varsinais-Suomen hyvinvointialue

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

19 Sep 2024 → ongoing

Decision date (initial)

2024-06-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514831-34-00

EudraCT number

2021-000827-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Assessment of cN-stage accuracy of Ferumoxtran-10-enhanced USPIO-MRI compared to histopathologic pN-stage of newly-diagnosed RC patients

Secondary objectives 1

1. Effects of Ferumoxtran-10-enhanced USPIO-MRI cN-stage assessment on treatment planning compared to conventional MRI.

Conditions and MedDRA coding

Rectal cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Voluntarily given and written informed consent. • Males and females over 18 years of age. • Newly diagnosed rectal cancer patients scheduled for direct surgery or SCRT. • Female subjects must be not of child-bearing potential, defined as postmenopausal for at least 1 year or surgically sterile. • Women of childbearing potential (WOCBP) can be included if they take precautions against pregnancy during the study and for at least 3 months thereafter.

Exclusion criteria 1

1. • Subjects unable to provide written informed consent • Age under 18 • Metastatic disease • T1-disease • Allergy to Ferumoxtran-10 or known hypersensitivity to Ferumoxtran-10 or its components • Known history of drug allergy (including hypersensitivity) to other parenteral iron products • Prior severe allergic reactions, including severe asthma and acute drug-induced severe reactions • Clinically documented or risk of primary or secondary iron overloading (e.g. history of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple iron transfusions for any reason) • Breastfeeding or pregnant women • Women of childbearing potential who are not willing to use effective contraceptive precautions against pregnancy • Prior abdominopelvic radiation • Prior abdominopelvic malignancies • Patients deemed too frail for surgery • Contraindications for MRI (ferromagnetic metallic implants, claustrophobia, MR-incompatible pacemakers, MR-incompatible prosthetic heart valves, severe obesity etc.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Accuracy

Secondary endpoints 1

1. positive predictive value, negative predictive value, sensitivity, specificity.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Varsinais-Suomen hyvinvointialue

Sponsor organisation

Varsinais-Suomen hyvinvointialue

Address

Kiinamyllynkatu 4-8

City

Turku

Postcode

20520

Country

Finland

Scientific contact point

Organisation

Varsinais-Suomen hyvinvointialue

Contact name

Jaakko Vanhatalo

Public contact point

Organisation

Varsinais-Suomen hyvinvointialue

Contact name

Jaakko Vanhatalo

Locations

1 EU/EEA country · 1 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 3 files

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

Application history

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