5T4 Targeting Nanobody Probe for PET Imaging in Solid Tumors
8 maj 2026 uppdaterad av: Peking University Cancer Hospital & Institute
Preparation of 5T4 Tumor Novel Target Nanobody PET Probe and Clinical Translation in Lung Cancer
This study aims to evaluate a novel 5T4 targeted nanobody PET imaging tracer, 68Ga-MY, for the detection and evaluation of solid tumors.
The 5T4 oncofoetal antigen is considered a valuable tumor-associated antigen, which is expressed in many different cancers, but is rarely expressed in normal adult tissues. And cell surface expression of 5T4 is an important property for antibody-targeted therapies. It has been shown that 5T4 is expressed on tumour-initiating cells (TICs) and associated with worse clinical outcome. Moreover, decreased adherence due to 5T4 expression may be associated with cancer spread.
In this single-center, open-label, self-controlled study, approximately 20 patients with suspected or confirmed solid tumors will undergo PET/CT imaging using 68Ga-MY. The imaging results will be compared with 18F-FDG. The study will assess tracer uptake in tumor lesions and compare diagnostic performance between imaging methods. The results may help determine whether 68Ga-MY PET/CT can improve tumor detection, staging, and clinical evaluation in patients with solid tumors.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
20
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Hua Zhu
- Telefonnummer: 010-88196495
- E-post: zhuhuabch@pku.edu.cn
Studieorter
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
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Kontakt:
- Hua Zhu
- Telefonnummer: +86 010-88196495
- E-post: zhuhuaBCH@pku.edu.cn
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Patients with solid tumors;
- Presence of measurable lesions on imaging examinations;
- Expected survival ≥12 weeks.
Exclusion Criteria:
- Severe hepatic or renal dysfunction;
- Women who are planning pregnancy, pregnant, or breastfeeding;
- Unable to remain in supine position for 30 minutes;
- Refusal to participate in this clinical study;
- Diagnosis of claustrophobia or other psychiatric disorders;
- Other conditions deemed by the investigator as inappropriate for participation in the trial.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 68Ga-MY PET Imaging
All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-MY PET/CT scans.After the participant rests quietly for 40 minutes or 1 hour, whole-body imaging of the head and torso will be performed using a United Imaging uEXPLORER Whole-Body PET/CT scanner at 1 h, 2 h, and 3 h post-injection.
The scan range will cover from the vertex to the upper third of the thighs.
Participants who required a dynamic scan underwent a 40-min serial scan after injection of 68Ga-MY.
PET/CT static imaging was performed at 2 h and 3 h after injection.
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Alla studiedeltagare kommer att genomgå en 18F-FDG PET/CT-skanning.
68Ga-MY is an investigational tracer, and all participants will undergo 68Ga-MY scanning.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Radiation Dosimetry of 68Ga-MY
Tidsram: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
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Radiation Dosimetry Organ-absorbed doses (mGy/MBq) and effective dose (mSv/MBq) calculated from PET/CT data using OLINDA/EXM software based on the MIRD schema.
Organs assessed include, but are not limited to, the liver, spleen, kidneys, lungs, heart, bone marrow, and urinary bladder.
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1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
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Standardized Uptake Value (SUV)
Tidsram: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
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Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of 68Ga-MY in target lesions were observed.
SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue.
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1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection.
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The ratio of Tumor SUV to background SUV (SUVR)
Tidsram: 1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection
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SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue.
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1. From the start of drug administration to 14 days after injection 2.Dynamic PET/CT scanning from 0 to 40 minutes post-injection, followed by static scans at 1 hour, 2 hours, and 3 hours post-injection. 3.Prior to each patient injection
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Hua Zhu, Peking University Cancer Hospital & Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
30 juni 2027
Avslutad studie (Beräknad)
30 december 2027
Studieregistreringsdatum
Först inskickad
20 april 2026
Först inskickad som uppfyllde QC-kriterierna
8 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024YJZ64
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
In accordance with the ICMJE data-sharing guidelines and Chinese data-privacy laws, raw clinical and imaging data were not publicly available to prevent compromise of patient privacy.
However, the corresponding author will share deidentified patient-level data, imaging parameters (SUV values), and study protocol details if reasonably requested by the requestor.
Tidsram för IPD-delning
Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.
Kriterier för IPD Sharing Access
Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .