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

Histiocytosis Clinical Trial

— HISTIOGEN  

Official title:

Determination of Molecular Status, as Well as the Efficacy and Safety of Fluorodeoxyglucose (18F-FDG) in PET-CT Imaging in Juvenile Patients With Histiocytosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943211
• Other study ID #: HISTIOGEN.
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2021
• Est. completion date: June 23, 2026

Study information

• Verified date: January 2024
• Source: Institute of Mother and Child, Warsaw, Poland
• Contact: Katarzyna Maleszewska
• Phone: +48 22 32 77 205
• Email: klinika.onkologii[@]imid.med.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

HISTIOGEN clinical study is part of the POLHISTIO project. The POLHISTIO project is a non-commercial clinical trial aimed at optimizing the diagnosis and treatment of juvenile patients with histiocytosis. The project objectives are defined as follows: 1) to estimate the nature and frequency of mutations in patients with histiocytosis in both tumor tissues and free-circulating DNA; 2) to compare molecular test results with clinical data; 3) to evaluate the diagnostic usefulness of the status of molecular analysis (MRD) as a prognostic factor compared with other recognized factors. As part of the HISTIOGEN protocol, an immortalized cell line will be derived to study the pathogenesis of the disease, drug sensitivity, and drug resistance mechanisms. The project is intended to include patients from all over Poland

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 23, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

1. Patient under 18 years of age at the time of inclusion.

2. Histopathologically confirmed or suspected histiocytosis (based on prior test results).

3. Signing of informed consent for trial participation according with current legal regulations.

Exclusion Criteria:

1. Lack of inclusion criteria.

2. Pregnancy.

3. 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.

Related Conditions & MeSH terms

• Histiocytosis

Intervention

Drug:
• fluorodeoxyglucose (18F-FDG)
max 6 MGBq/kg, no more than 100

Locations

Country	Name	City	State
Poland	Mother and Child Institute	Warsaw	Mazovian

Sponsors (4)

Lead Sponsor	Collaborator
Anna Raciborska	Lukasiewicz Research Network, Maria Sklodowska-Curie National Research Institute of Oncology, Wroclaw University of Environmental and Life Sciences

Country where clinical trial is conducted

Poland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	OS (Overall Survival)	Overall Survival (OS) was defined as the time interval from the date of diagnosis to the date of death or to last follow-up date.	2 years
Secondary	Molecular relapse (in ct DNA)	Molecular relapse was defined as the time interval from the date of any mutation negativization to the date of positive results of any mutation	2 years