Evaluation of Safety, Pharmacokinetics, Distribution,Radiation Safety and Sensitivity/Specificity of PET/CT Imaging With 68Ga-NYM096 in Participants With IRM
A Phase I Study Assessing the Safety, Pharmacokinetics, Radioactivity Distribution,Radiation Safety and Preliminary Diagnostic Performance of 68Ga-NYM096 Injection in Participants With Indeterminate Renal Masses
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
This will be a prospective, open-label, single-center phase I study. Histological confirmation will serve as standard of truth, to assess sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as accuracy of 68Ga-NYM096 PET/CT Imaging.
A total of 20~40 participants with IRM scheduled for surgical resection will be enrolled and assigned to two dose groups. Each participant will receive a single injection of the assigned dose; dose escalation within the same participant is not permitted. The study includes screening period, dosing/imaging period, safety follow-up visit, and surgery follow-up period.
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096.
- Age ≥18 years at the time of signing the informed consent form;
- ECOG score 0-2;
- Life expectancy ≥6 months;
- Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;
- Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures
Exclusion Criteria:
- A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
- Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.
- Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
- Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
- Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.
- Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.
- Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus [HCV] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).
- Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.
- Other situations where the investigator considers the participant unsuitable for this study
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: ⁶⁸Ga-NYM096 Injection
|
Using a syringe to withdraw 68Ga-NYM096 injection, the dose will be administered via an intravenous injection
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Treatment-Emergent Adverse events [Safety and Tolerability]
Tidsramme: 4 days
|
Incidence of abnormal laboratory test results, abnormal vital signs and ECG
|
4 days
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: Li Huo, MD, Peking Union Medical College Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Neoplasmer
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Adenokarsinom
- Urologiske neoplasmer
- Karsinom
- Nyre-neoplasmer
- Karsinom, nyrecelle
Andre studie-ID-numre
Andre studie-ID-numre
- G09601
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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