Determination of Molecular Status, the Efficacy and Safety of Fluorodeoxyglucose in PET-CT Imaging

NCT04943211 | Recruiting Phase 3

• 1 other identifier: HISTIOGEN.
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, low intervention, open, single-center, non-commercial clinical trial to improve diagnostics in patients with histiocytosis by assessing the molecular profile of the tumor tissues, monitoring its presence in free-circulating DNA, and determining the efficacy of fluorodeoxyglucose (18F-FDG) in PET-CT imaging.

Conditions

Histiocytosis

Keywords

Langerhans cell histiocytosis (LCH); histiocytosis; Positron Emission Tomography (PET); molecular status; paediatric patients

Outcome Measures

Primary Outcomes (1)

• EFS - (event-free survival)

  Event-free survival (EFS) was defined as the time interval from the date of diagnosis to the date of disease progression, recurrence, second malignancy, death or to date of last follow-up for patients without events.

  2 years

Secondary Outcomes (2)

• OS (Overall Survival)

  2 years

• Molecular relapse (in ct DNA)

  2 years

Study Arms (1)

R1 low intervention arm

OTHER

Children of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study.

Drug: fluorodeoxyglucose (18F-FDG)

Interventions

fluorodeoxyglucose (18F-FDG) DRUG

max 6 MGBq/kg, no more than 100

Also known as: GLUNEKTIK; SYNEKTIK

R1 low intervention arm

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histopathologically confirmed or suspected histiocytosis (based on prior test results).
• Signing of informed consent for trial participation according with current legal regulations.

You may not qualify if:

• Pregnancy.
• Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.

Sponsors & Collaborators

• Wrocław University of Environmental and Life Sciences: collaborator
• Łukasiewicz Research Network: collaborator
• Anna Raciborska: lead
• Maria Sklodowska-Curie National Research Institute of Oncology: collaborator

Study Sites (1)

Mother and Child Institute

Warsaw, Mazovian, 01-211, Poland

RECRUITING

Related Publications (11)

• Abla O, Jacobsen E, Picarsic J, Krenova Z, Jaffe R, Emile JF, Durham BH, Braier J, Charlotte F, Donadieu J, Cohen-Aubart F, Rodriguez-Galindo C, Allen C, Whitlock JA, Weitzman S, McClain KL, Haroche J, Diamond EL. Consensus recommendations for the diagnosis and clinical management of Rosai-Dorfman-Destombes disease. Blood. 2018 Jun 28;131(26):2877-2890. doi: 10.1182/blood-2018-03-839753. Epub 2018 May 2.

  PMID: 29720485 BACKGROUND

• Andersson D, Fagman H, Dalin MG, Stahlberg A. Circulating cell-free tumor DNA analysis in pediatric cancers. Mol Aspects Med. 2020 Apr;72:100819. doi: 10.1016/j.mam.2019.09.003. Epub 2019 Sep 25.

  PMID: 31563277 BACKGROUND

• Badalian-Very G, Vergilio JA, Degar BA, MacConaill LE, Brandner B, Calicchio ML, Kuo FC, Ligon AH, Stevenson KE, Kehoe SM, Garraway LA, Hahn WC, Meyerson M, Fleming MD, Rollins BJ. Recurrent BRAF mutations in Langerhans cell histiocytosis. Blood. 2010 Sep 16;116(11):1919-23. doi: 10.1182/blood-2010-04-279083. Epub 2010 Jun 2.

  PMID: 20519626 BACKGROUND

• Donadieu J, Piguet C, Bernard F, Barkaoui M, Ouache M, Bertrand Y, Ibrahim H, Emile JF, Hermine O, Tazi A, Genereau T, Thomas C. A new clinical score for disease activity in Langerhans cell histiocytosis. Pediatr Blood Cancer. 2004 Dec;43(7):770-6. doi: 10.1002/pbc.20160.

  PMID: 15390280 BACKGROUND

• Fanti S, Franchi R, Battista G, Monetti N, Canini R. PET and PET-CT. State of the art and future prospects. Radiol Med. 2005 Jul-Aug;110(1-2):1-15. English, Italian.

  PMID: 16163136 BACKGROUND

• Goyal G, Heaney ML, Collin M, Cohen-Aubart F, Vaglio A, Durham BH, Hershkovitz-Rokah O, Girschikofsky M, Jacobsen ED, Toyama K, Goodman AM, Hendrie P, Cao XX, Estrada-Veras JI, Shpilberg O, Abdo A, Kurokawa M, Dagna L, McClain KL, Mazor RD, Picarsic J, Janku F, Go RS, Haroche J, Diamond EL. Erdheim-Chester disease: consensus recommendations for evaluation, diagnosis, and treatment in the molecular era. Blood. 2020 May 28;135(22):1929-1945. doi: 10.1182/blood.2019003507.

  PMID: 32187362 BACKGROUND

• Haupt R, Minkov M, Astigarraga I, Schafer E, Nanduri V, Jubran R, Egeler RM, Janka G, Micic D, Rodriguez-Galindo C, Van Gool S, Visser J, Weitzman S, Donadieu J; Euro Histio Network. Langerhans cell histiocytosis (LCH): guidelines for diagnosis, clinical work-up, and treatment for patients till the age of 18 years. Pediatr Blood Cancer. 2013 Feb;60(2):175-84. doi: 10.1002/pbc.24367. Epub 2012 Oct 25.

  PMID: 23109216 BACKGROUND

• Heitzer E. Circulating Tumor DNA for Modern Cancer Management. Clin Chem. 2019 Oct 31:clinchem.2019.304774. doi: 10.1373/clinchem.2019.304774. Online ahead of print. No abstract available.

  PMID: 31672857 BACKGROUND

• Janku F, Diamond EL, Goodman AM, Raghavan VK, Barnes TG, Kato S, Abdel-Wahab O, Durham BH, Meric-Bernstam F, Kurzrock R. Molecular Profiling of Tumor Tissue and Plasma Cell-Free DNA from Patients with Non-Langerhans Cell Histiocytosis. Mol Cancer Ther. 2019 Jun;18(6):1149-1157. doi: 10.1158/1535-7163.MCT-18-1244. Epub 2019 Apr 23.

  PMID: 31015311 BACKGROUND

• Murakami I, Gogusev J, Jaubert F, Matsushita M, Hayashi K, Miura I, Tanaka T, Oka T, Yoshino T. Establishment of a Langerhans cell histiocytosis lesion cell line with dermal dendritic cell characteristics. Oncol Rep. 2015 Jan;33(1):171-8. doi: 10.3892/or.2014.3567. Epub 2014 Oct 24.

  PMID: 25351656 BACKGROUND

• Raciborska A, Bilska K, Weclawek-Tompol J, Gryniewicz-Kwiatkowska O, Hnatko-Kolacz M, Stefanowicz J, Pieczonka A, Jankowska K, Pierelejewski F, Ociepa T, Sobol-Milejska G, Muszynska-Roslan K, Michon O, Badowska W, Radwanska M, Drabko K. Clinical characteristics and outcome of pediatric patients diagnosed with Langerhans cell histiocytosis in pediatric hematology and oncology centers in Poland. BMC Cancer. 2020 Sep 11;20(1):874. doi: 10.1186/s12885-020-07366-3.

  PMID: 32917181 BACKGROUND

MeSH Terms

Conditions

Histiocytosis; Histiocytosis, Langerhans-Cell

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Anna Raciborska

  Mother and Child Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarzyna Maleszewska

CONTACT

+48 22 32 77 205; klinika.onkologii@imid.med.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Ass

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: April 1, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 25, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)