Clinical Trial Page

Summary
EudraCT Number:2019-002597-32
Sponsor's Protocol Code Number:AGO/2019/003
National Competent Authority:Belgium - FPS Health-DGM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2019-11-28
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedBelgium - FPS Health-DGM
A.2EudraCT number2019-002597-32
A.3Full title of the trial
Dynamics and tracer distribution of Tilmanocept using combined subareolar and peritumoral injection technique for scintigraphic sentinel lymph node detection in early stage breast cancer.
Vergelijking van dynamiek en tracerdistributie van nanocoll en tilmanocept bij gecombineerde subareolaire en peritumorale injectechniek voor scintigrafische sentinelklierdetectie bij vroegtijdige stadia van mammacarcinoma
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Sentinelklier opsporing bij borstcarcinoom door middel van de nieuw beschikbare tracer “Tilmanocept” of de gebruikelijke tracer “Nanocoll” – vergelijking van de tracerverdeling over de tijd.
A.4.1Sponsor's protocol code numberAGO/2019/003
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUniversity Hospital Ghent
B.1.3.4CountryBelgium
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportUniversity Hospital Ghent
B.4.2CountryBelgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationUniversity Hospital Ghent
B.5.2Functional name of contact pointHIRUZ CTU
B.5.3 Address:
B.5.3.1Street AddressC. Heymanslaan 10
B.5.3.2Town/ cityGhent
B.5.3.3Post code9000
B.5.3.4CountryBelgium
B.5.4Telephone number+329 3320500
B.5.5Fax number+3293320520
B.5.6E-mailhiruz.ctu@uzgent.be
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Lymphoseek
D.2.1.1.2Name of the Marketing Authorisation holderNorgine B.V.
D.2.1.2Country which granted the Marketing AuthorisationNetherlands
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameLymphoseek
D.3.4Pharmaceutical form Lyophilisate for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPPeritumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNtilmanocept
D.3.9.1CAS number 1185986-76-8
D.3.9.3Other descriptive nameTILMANOCEPT
D.3.9.4EV Substance CodeSUB119775
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product Yes
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Nanocoll
D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare BVBA
D.2.1.2Country which granted the Marketing AuthorisationBelgium
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameNanocoll
D.3.4Pharmaceutical form Powder for solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPPeritumoral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNNanocolloidal human albumin
D.3.9.3Other descriptive nameNANOCOLLOIDAL HUMAN ALBUMIN
D.3.9.4EV Substance CodeSUB190330
D.3.10 Strength
D.3.10.1Concentration unit µg microgram(s)
D.3.10.2Concentration typeequal
D.3.10.3Concentration number500
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product Yes
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Early stage breast cancer (T1, T2)
E.1.1.1Medical condition in easily understood language
breast cancer
E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 20.0
E.1.2Level PT
E.1.2Classification code 10006187
E.1.2Term Breast cancer
E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Documenting the distribution of 99m-Tc Tilmanocept at multiple timepoints post-injection (combined peritumoral and subareolar) and comparing this data with the distribution of 99m-Tc nanocoll at the same timepoints.
E.2.2Secondary objectives of the trial
Not applicable
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
-Women with newly diagnosed stage 1 or 2 breast cancer
-Clinically “node negative” (no clinically enlarged lymph nodes)
-Equal or more than 18 years old
E.4Principal exclusion criteria
-Pregnancy
-Previous surgery in the same breast
E.5 End points
E.5.1Primary end point(s)
Time to identification of first lymph node
E.5.1.1Timepoint(s) of evaluation of this end point
Lymph node count to background ratio 4 hours post-injection
Lymph node count to background ratio 24 hours post-injection
Injection site count to background ratio 4 hours post-injection
Injection site count to background ratio 24 hours post-injection
E.5.2Secondary end point(s)
Not applicable
E.5.2.1Timepoint(s) of evaluation of this end point
Not applicable
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy No
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other Yes
E.8.2.3.1Comparator description
Nanocoll
E.8.2.4Number of treatment arms in the trial2
E.8.3 The trial involves single site in the Member State concerned Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial has a data monitoring committee No
E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
LVLS + 180 days for prospective data collection
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 30
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 30
F.2 Gender
F.2.1Female Yes
F.2.2Male No
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state60
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
Standard of care
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2020-01-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2020-03-16
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2021-01-05

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