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[18F]Fluorthanatrace - Positron Emission Tomography (FTT-PET) and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)

2026年7月19日 更新者：Washington University School of Medicine

Integration of FTT-PET and ctDNA to Predict Response to PARP Inhibitor Therapy in Metastatic Prostate Cancer (mPC)

This multicenter center, open-label, baseline-controlled diagnostic imaging study designed to assess the use of Fluorthanatrace-Positron Emission tomography (FTT-PET) as a PARP inhibitor (PARPi) therapy predictive imaging biomarker and the use of EnhanceAR-Seq (ctDNA) in predicting response to therapy and to identify genomic alterations associated with resistance. Furthermore, to correlate changes in ctDNA and imaging (FTT-PET and standard of care imaging) to understand the dynamics of tumor response.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

75

段階

  • フェーズ2

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Missouri
      • St Louis、Missouri、アメリカ、63110
        • Washington University School of Medicine
        • コンタクト：
        • 副調査官：
          • Richard Laforest, PhD
        • 副調査官：
          • Kooresh I Shoghi, PhD
        • 副調査官：
          • Christopher A Maher, PhD
        • 副調査官：
          • Cody Weimholt, MD
        • 副調査官：
          • Melissa A Reimers, MD
        • 副調査官：
          • Yu Tao, MD
        • 副調査官：
          • Buck Rogers, PhD
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • University of Pennsylvania Abramson Cancer Center
        • コンタクト：
        • 主任研究者：
          • Nei Taunk, MD
    • Texas
      • Houston、Texas、アメリカ、77030
        • University of Texas MD Anderson Cancer Center
        • コンタクト：
          • Lilie Lin, MD
          • 電話番号：713-792-2121
        • 主任研究者：
          • Lilie Lin, MD
        • 副調査官：
          • Franklin Wong, MD
        • 副調査官：
          • Patrick G Pilie, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Adult male patients 18 years of age or older
  • mCRPC with confirmed germline or somatic HRR (such as ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C for Talazoparib/enzalutamide and ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm; gBRCA1m, gBRCA2m; ATMm, BRCA1m, BRCA2m for Olaparib +/- abiraterone) mutations who are scheduled for SOC PARPi therapy.
  • Lesion size of at least 1.0 cm in longest dimension by imaging. If non-measurable, lesion needs to be clearly detected on other imaging studies such as bone scintigraphy, FDG-PET, PSMA-PET or MRI.
  • On continuous androgen deprivation therapy (ADT) with appropriately suppressed castrate testosterone levels of < 50 ng/dL, or prior bilateral orchiectomy.
  • Serum PSA of 2 ng/mL or greater.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Able to give informed consent

Exclusion Criteria:

  • Receipt of prior PARP inhibitor therapy in any disease setting.
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer that is active at the time of enrollment.
  • Unable to tolerate approximately 30 min (total time) of PET/CT imaging.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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：FTT-PET/CT

Participants will undergo two FluorThanatrace (FTT) Positron Emission Tomography/Computed tomography (PET/CT) scans; one at baseline prior to starting standard of care (SOC) PARP inhibitor (PARPi) therapy and one two weeks after initiation of PARPi therapy. Each cycle of PARPi therapy is 28 days.

Blood samples for EnhanceAR-Seq ctDNA analysis will be collected from participants at baseline prior to therapy, post cycle 1,12 weeks after PARPi initiation, and at time of disease progression.

Eight participants will undergo an additional FTT-PET/CT prior to initiation of PARPi therapy.
薬：1-(4-(2-Fluoroethoxy)phenyl)-8,9-dihiydro-2,7,9a-triazabenzo[cd]azulen-6(7H)-one
[18F]fluorthanatrace (FTT) is a positron emitting radiopharmaceutical that is administered as an intravenous (IV) solution via injection at a prescribed dose of 10mCi. A lesser dose may be injected if complete imaging data could be generated.
他の名前：
  • [18F]フロルタナトレース
  • [18F]FTT
  • FTT
デバイス：FTT-PET/CT
A small intravenous (IV) catheter will be placed in the arm vein according to site's standard practice to allow injection of FTT. Approximately sixty minutes following administration of approximately 10 mCi of the radiotracer FTT, patients will undergo standard body PET/CT imaging.
診断テスト：EnhanceAR-Seq
Patients will undergo approximately 30 mL of peripheral blood sample collection to be used for analysis. For each sample, EnhanceAR-Seq will be performed on each of these samples, with somatic genomic alteration calling performed in plasma cell-free DNA with removal of background non-tumor variants using matched plasma-depleted whole blood germline samples.

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
Prediction performance of FTT-PET as measured by concordance index (C-index)
時間枠：At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is mathematically calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET as measured by area under the receiver operating characteristic (ROC) curve
時間枠：At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of FTT-PET in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy and post cycle 1 (estimated total time 28 days)
Prediction performance of EnhanceAR-Seq ctDNAas measured by concordance index (C-index)
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA analysis in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA as measured by area under the receiver operating characteristic (ROC) curve
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of EnhanceAR-Seq ctDNA analysis in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by concordance index (C-index)
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA analysis collectively in predicting participant response to PARPi therapy will be assessed by concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA collectively as measured by area under the receiver operating characteristic (ROC) curve
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-Seq ctDNA analysis collectively in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), and at progression if applicable (estimated total time 6 months)
Sensitivity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Sensitivity is calculated as the proportion of true positives divided by the sum of true positives and false negatives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate sensitivity. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Specificity of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Specificity is calculated as the proportion of true negatives divided by the sum of true negatives and false positives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate specificity. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes the performance of model. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Positive predictive value (PPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
PPV is calculated as the number of true positives divided by the sum of the number of true positives and number of false positives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate PPV. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Negative predictive value (NPV) of EnhanceAR-Seq ctDNA in identifying mPC patients who respond to PARPi therapy
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
NPV is calculated as the number of true negatives divided by the sum of the number of true negatives and number of false negatives. The area under the Receiver Operating Characteristic (ROC) curve will be calculated to identify the optimal cutpoint on the ROC corresponding to the maximized Youden index to evaluate NPV. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by change in concordance index of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-seq ctDNA in predicting participant response to PARPi therapy will be assessed by the concordance index (C-index). The C-index is calculated as the number of concordant pairs divided by the number of comparable pairs. A C-index of 1 indicates perfect ranking, values close to 0.5 indicate random prediction, and values between 0.5 and 1 suggest some predictive ability prediction (a value below 0.5 can be reversed by switching the response's 0 and 1 labels).
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Predictive performance improvement as measured by area under the receiver operating characteristic (ROC) curve of FTT-PET and EnhanceAR-seq ctDNA compared to only FTT-PET or only EnhanceAR-seq ctDNA
時間枠：At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)
Prediction performance of FTT-PET and EnhanceAR-seq ctDNA in predicting participant response to PARPi therapy will be assessed by the area under the ROC curve. The ROC curve is a graphical plot that illustrates the performance of a model at various threshold settings and the area under the curve (AUC) is a single scalar value between 0 and 1 that summarizes model performance. A higher AUC value indicates better performance.
At baseline prior to PARPi therapy, post cycle 1 (cycle is an estimated 28 days), 12 weeks after start of PARPi therapy, and at progression if applicable (estimated total time 6 months)

二次結果の測定

結果測定
メジャーの説明
時間枠
Test-Retest Only: Lin's intra-class correlation coefficient of FTT-PET imaging
時間枠：At baseline prior to PARPi therapy, at retest scan 1-14 days after baseline scan, and post-cycle 1 (estimated total time 28 days)
Defined as concordance between a new test or measurement (Y) and a gold standard test or measurement (X). This statistic quantifies the agreement between these two measures of the same variable. Ranges from -1 to 1, with perfect agreement at 1.
At baseline prior to PARPi therapy, at retest scan 1-14 days after baseline scan, and post-cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and tumor mutation burden (TMBddr) as assessed by Spearman or Pearson correlation coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

TMBddr is the number of genetic mutation in tumor cells that can affect patient response and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and variant allele frequency (VAF) as assessed by Spearman or Pearson correlation coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

VAF represents the fraction of variant sequencing reads within a genetic locus and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and dynamic changes in ctDNA levels as assessed by Spearman or Pearson correlation coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

Dynamic changes in ctDNA refer to measurable changes in circulating tumor DNA in patient's blood over time and will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and prostate-specific antigen (PSA) levels as assessed by Spearman or Pearson correlation coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

Changes PSA levels in the blood over time will be assessed through EnhanceAR-Seq ctDNA.

Spearman's correlation coefficient evaluates the association and the association's direction between two ranked continuous variables. Spearman's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.

Pearson's correlation coefficient is a measure that evaluates the association between two continuous variables with the assumption that the variables have a linear relationship. Pearson's correlation coefficient ranges from -1 to 1, with a negative number indicating a negative relationship between variables and a positive number indicating a positive relationship between variables. Values closer to zero indicate a weak relationship.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and tumor mutation burden (TMBddr) as assessed by Kappa agreement coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

TMBddr is the number of genetic mutation in tumor cells that can affect patient response and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluated inter-rater reliability. Kappa coefficient scores range from -1 to 1 with scores closer to 0 indicate poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and variant allele frequency (VAF) as assessed by Kappa agreement coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

VAF represents the fraction of variant sequencing reads within a genetic locus and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluate inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and dynamic changes in ctDNA level as assessed by Kappa agreement coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

Dynamic changes in ctDNA refer to measurable changes in circulating tumor DNA in patient's blood over time and will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluated inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Correlation between FTT-PET imaging and prostate-specific antigen (PSA) as assessed by Kappa agreement coefficient
時間枠：At baseline and post cycle 1 (estimated total time 28 days)

Changes PSA levels in the blood over time will be assessed through EnhanceAR-Seq ctDNA.

The Kappa agreement measure is calculated to evaluate inter-rater reliability. Kappa coefficient scores range from -1 to 1, with scores closer to 0 indicating poor or little agreement and scores of 1 or -1 indicating perfect agreement.
At baseline and post cycle 1 (estimated total time 28 days)
Association of FTT-PET and EnhanceAR-Seq metrics with patient response based on relative risk
時間枠：From enrollment to time of progression (estimated total time 6 months)
Relative risk is a measure of the ratio of the risk of a certain event in an exposed group compared to the risk of the same event in a control group. A relative risk of 1.0 indicates no difference in risk between the groups, greater than 1.0 indicates increased risk in the exposed group, and less than 1.0 indicates decreased risk in the exposed group.
From enrollment to time of progression (estimated total time 6 months)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Washington University School of Medicine

協力者

National Cancer Institute (NCI)

捜査官

  • 主任研究者：Farrokh Dehdashti, MD、Washington University School of Medicine

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2032年3月31日

研究の完了 (推定)

2032年3月31日

試験登録日

最初に提出

2026年7月19日

QC基準を満たした最初の提出物

2026年7月19日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月19日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 202605165

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?

はい

IPD プランの説明

De-identified individual participant data collected during the trial, metadata collection, and supporting files will be shared via National Cancer Institute (NCI) repositories. Deidentified clinical images will be shared through The Cancer Imaging Archive (TCIA) and the Imaging Data Commons (IDC) of NCI. Genomic data will be shared via the NCI Genomic Data Commons (GDC).

IPD 共有時間枠

Data will be available as soon as possible, but no later than the time of publication or the end of the funding period, whichever comes first. The duration of preservation and sharing of the data will be determined based on timelines established by respective NCI repositories.

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

はい

米国FDA規制機器製品の研究

はい

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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