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HistiocytosisPhase 3HISTIOGENNCT04943211

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

A Phase 3 study testing fluorodeoxyglucose (18F-FDG) in people with Histiocytosis, run by Anna Raciborska at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 1 year to 18 years
Conditions the study is for
Histiocytosis
What is being tested?
fluorodeoxyglucose (18F-FDG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 sitePoland
Study dates
1 Apr 2021to 30 Jun 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patient under 18 years of age at the time of inclusion.
  • Histopathologically confirmed or suspected histiocytosis (based on prior test results).
  • Signing of informed consent for trial participation according with current legal regulations.

Who cannot join

  • Lack of inclusion criteria.
  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Mother and Child Institute

    Warsaw, Mazovian, 01-211

Other trials in Poland

About this study

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

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.

Read the detailed 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

Conditions
Histiocytosis
Being tested
fluorodeoxyglucose (18F-FDG)
Keywords
Langerhans cell histiocytosis (LCH), histiocytosis, Positron Emission Tomography (PET), molecular status, paediatric patients
Medical subject headings
Histiocytosis, Histiocytosis, Langerhans-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluorodeoxyglucose (18F-FDG)Drug

    Also called GLUNEKTIK; SYNEKTIK

    max 6 MGBq/kg, no more than 100

Study groups in NCT04943211
Study groupRoleWhat they receive
R1 low intervention armOtherChildren of both sexes who meet all inclusion criteria and do not meet any exclusion criteria will be eligible for the study.
Receives: Drug: fluorodeoxyglucose (18F-FDG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (2)

  1. 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.

    Measured: 2 years

  2. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start1 Apr 2021
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04943211
Sponsor's protocol ID
HISTIOGEN.
Acronym
HISTIOGEN
Status last verified
Oct 2026
First submitted
21 Jun 2021
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29720485

  • 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.

    PubMed 31563277

  • 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.

    PubMed 20519626

  • 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.

    PubMed 15390280

  • 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.

    PubMed 16163136

  • 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.

    PubMed 32187362

  • 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.

    PubMed 23109216

  • 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.

    PubMed 31672857

  • 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.

    PubMed 31015311

  • 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.

    PubMed 25351656

  • 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.

    PubMed 32917181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fluorodeoxyglucose (18F-FDG) in people with Histiocytosis, run by Anna Raciborska at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFS - (event-free survival) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04943211, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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