固形腫瘍における PET イメージング用の PD-L1 特異的 [68Ga]-Nb-1 ナノボディ プローブ
To utilize the [68Ga]Ga-THP-PDL1-3 molecular probe to non-invasively detect PD-L1 expression in primary and metastatic lesions of patients with solid tumors. Furthermore, to assess the heterogeneity of PD-L1 expression within the same lesion and across different lesions, and to observe changes in PD-L1 expression during the course of treatment. This approach aims to facilitate patient screening, therapeutic monitoring, and early warning of drug resistance and/or recurrence or metastasis in the treatment of solid tumors with high PD-L1 expression, ultimately enabling personalized targeted therapy in oncology.
調査の概要
詳細な説明
Analysis plan: 1. recruit 10 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution and tumor uptake information via whole-body PET/CT imaging; 2. recruit 20-30 participants to analyze in vivo safety and tumor targeting information; and 3. recruit all participants for a final summary.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100142
- Beijing Cancer Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Age 18-70 years, ECOG score 0 or 1;
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：[68Ga]Ga-THP-PDL1-3
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [68Ga]Ga-THP-PDL1-3 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]Ga-THP-PDL1-3. PET/CT static imaging was performed at 2 h and 3 h after injection. |
All study participants will undergo one 18F-FDG PET/CT scan. [68Ga]Ga-THP-PDL1-3 is an investigational tracer, and all participants will undergo [68Ga]Ga-THP-PDL1-3 scanning. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety and Feasibility
時間枠：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.
|
Safety and feasibility were evaluated by no adverse events after comprehensive indicators. |
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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Standardized Uptake Value (SUV)
時間枠：Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
|
Parameters of SUV The maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean) and tumor/background ratio (SUVR) of [68Ga]Ga-THP-PDL1-3 in target lesions were observed. SUVR was calculated as the SUVmax of the target lesion divided by the SUVmean of the reference normal tissue. |
Quantitative analysis was performed at all imaging time points within two weeks after the end of imaging.
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Hua Zhu、Peking University Cancer Hospital & Institute
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2022KT74-ZY01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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.
IPD 共有時間枠
Data access will be granted through a secure data sharing agreement for a period of 3 years after publication.
IPD 共有アクセス基準
Applicants must provide a methodologically sound research plan and obtain approval from their institutional ethics committee.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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