Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
12 juli 2026 bijgewerkt door: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
A Single-Center, Prospective, Open-Label Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry, and Diagnostic Performance of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Adult Patients With Solid Tumors
This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of [68Ga]Ga-FFD PET imaging.
The study consists of two cohorts: healthy volunteers and adult patients with histologically or clinically confirmed malignant solid tumors.
Healthy volunteers will undergo serial PET imaging to evaluate tracer biodistribution, pharmacokinetics, and radiation dosimetry.
Patients will undergo [68Ga]Ga-FFD PET imaging in addition to standard-of-care ^18F-FDG PET imaging for assessment of lesion detection and diagnostic performance.
Safety will be evaluated through adverse event monitoring, vital signs, laboratory tests, physical examinations, and electrocardiography.
Diagnostic performance will be assessed using histopathology, conventional imaging, and clinical follow-up as the reference standard.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
This first-in-human study evaluates the clinical performance of [68Ga]Ga-FFD, a novel PET radiotracer for molecular imaging of malignant tumors.
Healthy volunteers will undergo serial whole-body PET imaging after a single intravenous administration of [68Ga]Ga-FFD to characterize biodistribution, organ uptake, pharmacokinetics, and radiation dosimetry.
Adult patients with malignant solid tumors will undergo [68Ga]Ga-FFD PET/CT and standard-of-care ^18F-FDG PET/CT imaging.
Diagnostic performance, including lesion detection and patient-based diagnostic accuracy, will be compared between the two imaging modalities.
Radiation dosimetry will be estimated using time-activity curves and the OLINDA/EXM software based on the MIRD methodology.
Safety assessments will include adverse events, laboratory evaluations, electrocardiography, physical examinations, and vital signs.
Studietype
Ingrijpend
Inschrijving (Geschat)
12
Fase
- Vroege fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Xiaoli Lan
- Telefoonnummer: 0086-027-83692633
- E-mail: lxl730724@hotmail.com
Studie Locaties
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Hubei
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Wuhan, Hubei, China
- Union Hospital, Huazhong University of Science and Technology
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Contact:
- Xiaoli Lan
- Telefoonnummer: 0086-027-83692633
- E-mail: lxl730724@hotmail.com
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Contact:
- E-mail: lxl730724@hotmail.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
- Written informed consent obtained before any study-specific procedures. Adults aged 18 years or older.
- Healthy volunteers or patients with histologically, cytologically, or clinically confirmed malignant solid tumors.
- ECOG performance status of 0-1 for patients.
- Clinical indication for ^18F-FDG PET/CT imaging (patient cohort only).
- Adequate organ function.
- Willing and able to comply with all study procedures.
Exclusion Criteria:
- Pregnant or breastfeeding women.
- Known hypersensitivity to gallium-containing radiopharmaceuticals or any component of the investigational product.
- Clinically significant uncontrolled cardiovascular, hepatic, renal, hematologic, neurological, or psychiatric disease.
- Active uncontrolled infection requiring systemic treatment.
- Receipt of investigational drugs or participation in another interventional clinical study within 30 days before enrollment.
- Previous anticancer therapy that does not satisfy the protocol-defined washout period (patient cohort only).
- Inability to undergo PET/CT imaging or comply with study procedures. Any condition that, in the investigator's judgment, would compromise participant safety or interfere with study assessments.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: [68Ga]Ga-FFD PET Imaging
Participants will receive a single intravenous administration of [68Ga]Ga-FFD followed by serial whole-body PET/CT imaging.
Healthy volunteers will undergo imaging for biodistribution and radiation dosimetry evaluation, while patients with malignant solid tumors will additionally undergo standard-of-care ^18F-FDG PET/CT imaging for assessment of diagnostic performance.
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For Cancer patients, [68Ga]Ga-FFD is a gallium-68-labeled PET radiotracer administered as a single intravenous injection at approximately 185 MBq (5 mCi ±10%) for molecular imaging.
Whole-body PET/CT imaging will be performed at approximately 0.5 and 2 hours after administration to evaluate tracer biodistribution, radiation dosimetry, safety, and diagnostic performance.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Visual and standardized uptake values assessment of lesions and biodistribution
Tijdsspanne: one month
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PET images will be independently reviewed by at least two experienced nuclear medicine physicians who are blinded to each other's interpretations.
Histopathological findings, when available, together with clinical and imaging follow-up, will serve as the reference standard for lesion verification.
Both visual and semiquantitative analyses will be performed for each participant.
Semiquantitative analysis will include measurement of the maximum and mean standardized uptake values (SUVmax and SUVmean) of tumor lesions and major normal organs at each imaging time point.
Lesion detection, tracer biodistribution, tumor-to-background ratios, and image quality will also be evaluated.
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one month
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Incidence of Treatment-Emergent Adverse Events
Tijdsspanne: From administration of [68Ga]Ga-FFD through 7 days after PET imaging.
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Safety will be evaluated by assessing the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), together with changes in vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms following administration of [68Ga]Ga-FFD.
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From administration of [68Ga]Ga-FFD through 7 days after PET imaging.
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Biodistribution of [68Ga]Ga-FFD
Tijdsspanne: Approximately 0.5 hours and 2 hours after tracer administration.
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Percentage of injected dose (%ID), SUVmean, and residence time in major organs and tissues will be measured at each imaging time point.
Time-activity curves will be generated for quantitative biodistribution analysis.
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Approximately 0.5 hours and 2 hours after tracer administration.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
30 juli 2026
Primaire voltooiing (Geschat)
30 juli 2027
Studie voltooiing (Geschat)
30 juli 2027
Studieregistratiedata
Eerst ingediend
12 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 juli 2026
Eerst geplaatst (Werkelijk)
16 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
12 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- Xlan-20260332
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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