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Biodistribution, Dosimetry, and Safety of 68Ga-EV203 in Hematological Malignancies

23 giugno 2026 aggiornato da: He-Qing Yi, Zhejiang Cancer Hospital

A Clinical Translational Study Evaluating the Biodistribution, Radiation Dosimetry, and Safety of 68Ga-EV203 Injection in Patients With Hematological Malignancies

The goal of this clinical trial is to evaluate the biodistribution, radiation dosimetry, safety, and time-dependent image quality of ^68^Ga-EV203 injection in patients with hematological malignancies (multiple myeloma, non-Hodgkin lymphoma, or acute myeloid leukaemia), aged 18-75 years, who are able to lie still for 0.5 h and have no contraindications (e.g., pregnancy, recent radiotherapy, etc.).

The main questions it aims to answer are:

What are the biodistribution (organ uptake, %ID, SUV) and radiation absorbed doses (mGy/MBq) of ^68^Ga-EV203 in target organs and the whole body?

What is the safety profile of ^68^Ga-EV203, as measured by adverse events and serious adverse events?

How does the PET/CT image quality differ between the 30-, 60-, 90-, and 120-minute time points after injection?

If there is a comparison group: Researchers will compare the positive percent agreement (PPA) and positive predictive value agreement (PPrA) of ^68^Ga-EV203 PET/CT against ^18^F-FDG PET/CT to see if the new tracer offers comparable or superior diagnostic performance in detecting CXCR4-positive lesions.

Participants will:

Receive a single intravenous injection of 74-296 MBq of ^68^Ga-EV203.

Undergo whole-body PET/CT scans at 30 min, 60 min, 90 min, and 120 min post-injection on the same day.

Return within 3-7 days (but at least 2 days later) for a standard ^18^F-FDG PET/CT scan after fasting for ≥5 h.

Attend a safety follow-up visit at day 8-14 for physical examination, vital signs, and laboratory tests (blood count, coagulation, and biochemistry).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310022
        • Reclutamento
        • Zhejiang Cancer Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Age 18 to 75 years (inclusive) at screening.
  • Able to lie still on the scanning bed for 0.5 hours.
  • Willing to sign informed consent and able to comply with protocol requirements.
  • Histologically/cytologically confirmed diagnosis of multiple myeloma (MM), non-Hodgkin lymphoma (NHL), or acute myeloid leukaemia (AML) according to the 2022 WHO Classification of Haematolymphoid Tumours.

Exclusion Criteria:

  • Has claustrophobia or any other condition that prevents tolerance of imaging procedures
  • Has undergone major surgery within 3 months prior to screening, or plans to undergo surgery during the study period.
  • Has received any other radiopharmaceutical imaging agent or therapeutic radiopharmaceutical within 30 days prior to screening.
  • Is pregnant or lactating at screening.
  • Is a woman of childbearing potential or a man who does not agree to use effective contraception during the study (from signing informed consent) and for 3 months after study drug administration.
  • Has a known allergy to alcohol or any component of the investigational product, or has other allergies judged by the investigator to increase the participant's risk.
  • Has clinically significant cardiovascular disease within 6 months prior to screening (e.g., myocardial infarction, unstable angina, symptomatic congestive heart failure, uncontrolled severe arrhythmia).
  • Has uncontrolled hypertension, or a history of coagulopathy or coagulation disorders.
  • Has been diagnosed with another malignancy (other than the target haematological disease) within 5 years prior to 68Ga-EV203 administration.
  • Has received any systemic anti-cancer therapy within 2 weeks prior to planned 68Ga-EV203 administration, or radiotherapy within 8 weeks prior to planned administration.
  • Has any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 68Ga-EV203 PET/CT Biodistribution, Dosimetry, and Safety Evaluation in Hematological Malignancies
Test diagnostico: 68Ga-EV203 PET/CT
This arm is distinguished by: (1) a novel CXCR4-targeting cyclic peptide, 68Ga-EV203, with >10-fold higher binding affinity than the benchmark 68Ga-Pentixafor, enabling superior tumor-to-background contrast. (2) Four sequential whole-body PET/CT scans at 30, 60, 90, and 120 min post-injection to construct time-activity curves and compute organ-specific absorbed doses (mGy/MBq) and effective dose (mSv/MBq) using OLINDA/EXM-a formal dosimetry endpoint absent in routine diagnostic imaging. (3) Mandatory paired 18F-FDG PET/CT within 3-7 days for direct intrapatient head-to-head diagnostic comparison . (4) Strict enrollment limited to three defined hematological subtypes (MM, NHL, AML) per WHO 2022, with explicit washout periods (≥2 weeks from last anticancer therapy, ≥8 weeks from radiotherapy). (5) A 14-day safety follow-up including laboratory tests (CBC, coagulation, biochemistry) and rigorous contraception requirements for 3 months post-dose.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Injected Dose (%ID) and Standardized Uptake Values (SUVmean and SUVmax) in Target Organs Measured by PET/CT Imaging
Lasso di tempo: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.
Radioactivity concentration in major organs (including brain, lungs, heart, liver, spleen, kidneys, bladder, bone, and gastrointestinal tract) is quantified as percentage of injected dose (%ID) and mean/maximum standardized uptake values (SUVmean/SUVmax) using three-dimensional volumes of interest (VOIs). Data will be summarized using descriptive statistics (mean, standard deviation, median, minimum, and maximum) across all participants.
Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.
Organ-Specific Radiation Absorbed Doses (mGy/MBq) and Whole-Body Effective Dose (mSv/MBq) Calculated via OLINDA/EXM Software
Lasso di tempo: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.
Time-activity curves (fitted with single- or bi-exponential models) are integrated to obtain cumulated activity for each organ. Absorbed doses (mGy/MBq) and whole-body effective dose (mSv/MBq) are computed using validated dosimetry software (OLINDA/EXM or MIRDcalc) with ICRP reference phantoms. Results will be reported as mean, standard deviation, and range across participants.
Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.
Number of Participants with Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Graded by NCI-CTCAE Version 5.0
Lasso di tempo: Adverse event monitoring begins from the time of injection on Day 1 and continues through the safety follow-up visit, which occurs between Day 8 and Day 14 post-injection.
All adverse events and serious adverse events occurring from study drug administration through the final safety visit are recorded and graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Data will be summarized as frequencies and percentages of participants experiencing each type and grade of event.
Adverse event monitoring begins from the time of injection on Day 1 and continues through the safety follow-up visit, which occurs between Day 8 and Day 14 post-injection.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Tumor-to-Background Ratios (TBR) Derived from PET/CT Images at Four Consecutive Post-Injection Time Points
Lasso di tempo: Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.
Tumor-to-background ratios (lesion SUVmax divided by liver SUVmean and by blood-pool SUVmean) are calculated at 30, 60, 90, and 120 minutes after injection to evaluate time-dependent image quality. Differences across time points will be summarized using paired descriptive statistics (means and standard deviations).
Day 1 - PET/CT scans are acquired at 30 minutes (±5 minutes), 60 minutes (±10 minutes), 90 minutes (±10 minutes), and 120 minutes (±15 minutes) after intravenous injection of 68Ga-EV203.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Zhejiang Cancer Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2029

Completamento dello studio (Stimato)

1 giugno 2029

Date di iscrizione allo studio

Primo inviato

18 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

26 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB-2026-483

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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