Data Sets

Data Set Filters

Data Set TypeModalityDisease TypesTreatment TypesAnalysis TypesNodes

Data Set Types

  • Archived

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Modality Types

  • CT Scan

  • PET Scan

  • MRI

  • Ultrasound

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  • Other

Disease Types

  • Lung

  • Lymphoma

  • Breast

  • Blood

  • Melanoma

  • Prostate

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Treatment Types

  • Radiation Therapy

  • Targeted Therapy

  • Chemo Therapy

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  • Other

Analysis Types

  • QTBI

  • QTMI

  • QTII

  • QTNI

  • QTSI

  • QTDI

  • QTCI

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Nodes

  • Madison

  • Lubjianja

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These are data sets that are part of the NIX database. Appropriate approvals need to be obtained to access this data

NIX-MSN-D1606 Data Set

Imaging Biomarkers to Validate Treatment Response in mCRPC

Summary

This study evaluated the feasibility of using NaF PET/CT imaging-based biomarkers for tumor biopsy procurement from patients with metastatic castration resistant prostate cancer and compared the lesion response to biomarkers from biopsies and Enzalutamide treated profiles.

  • Subjects: 7
  • Layout: mCRPC
  • Data Types: NaF PET/CT
  • Data Size: 9700

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • To determine the feasibility and success rate of tumor tissue procurement using molecular-image-directed biopsies of responding and non-responding osseous metastases, measured by NaF PET/CT, in patients with metastatic castrate-resistant prostate cancer.
Secondary Objectives
  • To compare NaF PET/CT responding lesions to known response molecular biomarkers obtained from biopsy of responding lesions.
  • To compare NaF PET/CT non-responding lesions to known resistance molecular biomarkers obtained from biopsy of non-responding lesions.
  • To determine NaF PET/CT -derived radiomic profiles that correlate with prolonged benefit (PFS > 12 month) to enzalutamide.
  • To correlate global responsiveness on NaF PET/CT (percentage of responding/non-responding lesions, SUVtotal) with clinical outcomes: PSA response, RECIST response, time to PSA progressions, and radiographic PFS.
NIX-MSN-D1512 Data Set

Evaluation of treatment response using FLT PET/CT in Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Summary

This phase II trial evaluated FLT PET/CT for early assessment of chemotherapy treatment response in previously untreated AML patients measured in terms of NPV, PPV of post-treatment FLT PET/CT imaging for complete remission and evaluated the feasibility of FLT PET/CT as a predictor of remission in AML.

  • Subjects: 7
  • Layout: FLT
  • Data Types: FLT PET/CT
  • Data Size: 27250

*Disclaimer: Approval Pending

Objectives
Primary Objectives
  • To evaluate the negative predictive value (NPV) of post-treatment FLT PET/CT imaging for complete remission (CR) in patients receiving induction chemotherapy for acute myeloid leukemia (AML).
Secondary Objectives
  • To evaluate the positive predictive value (PPV) of post-treatment FLT PET/CT imaging for complete remission.
  • To estimate the sensitivity and specificity of FLT PET/CT at complete remission detection.
  • To evaluate pre-treatment FLT PET/CT activity as a predictor of complete remission.
  • To evaluate the change between pre-treatment and post-treatment FLT PET/CT activity as a predictor of complete remission.
  • To correlate post-treatment FLT PET/CT imaging parameters with day 28 bone marrow aspirate/biopsy and minimal residual disease assessment by flow cytometry.
  • To correlate FLT PET/CT imaging parameters (maximum FLT uptake across the total bone marrow compartment [SUVmax], mean FLT uptake across the total bone marrow compartment [SUVmean], heterogeneity) with biologic correlates (minimal residual disease [MRD] assessment).
NIX-MSN-D1507 Data Set

Evaluation of Vaccine Therapy and Pembrolizumab in mCRPC Patients using NaF PET/CT

Summary

This pilot study evaluated the efficacy of an investigational vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP) and Pembrolizumab, in delaying disease progression in patients with castration-resistant metastatic prostate cancer.

  • Subjects:17
  • Layout: Immunotherapy/mCRPC
  • Data Types: NaF PET/CT
  • Data Size: 1400

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • To evaluate the safety of pembrolizumab in combination with pTVG-HP in patients with castration-resistant, metastatic prostate cancer.
  • To determine the 6-month progression-free survival and median time to radiographic progression in patients with castration-resistant metastatic prostate cancer treated with pembrolizumab in combination with pTVG-HP.
  • To evaluate the anti-tumor response rates (objective response rate and PSA response rate, using PCWG2 criteria) in patients with castration-resistant metastatic prostate cancer treated with pembrolizumab in combination with pTVG-HP.
Secondary Objectives
  • To determine whether either treatment sequence, or PAP-specific immune response, is associated with prolonged (6-month) radiographic progression-free survival
  • To evaluate effects of schedule (concurrent versus delayed administration of pembrolizumab) on the magnitude of PAP-specific T-cell responses, PD-1 expression on circulating T cells, and PD-L1 expression on circulating epithelial cells (CEC) and on tumor biopsies.
NIX-MSN-D1409 Data Set

Evaluation of Combination Therapy of VEGFR inhibitor and Docetaxel Using FLT-PET/CT in Patients with Advanced Solid Malignancies

Summary

This study utilized FLT-PET/CT to measure pharmacodynamic response and vascular parameters in patients with advanced solid malignant tumors when administered with VEGFR inhibitor and Docetaxel.

  • Subjects: 4
  • Layout: Anti-angiogenic
  • Data Types: FLT PET/CT
  • Data Size: 4250

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • To evaluate the safety and tolerability of intermittent X-82 when administered in a 2 week on, 1 week off schedule (Cycle #1)
  • To evaluate the safety and tolerability of intermittent X-82 administered in combination with docetaxel every 3 weeks (Cycle #2)
  • To determine the change in vascular parameters using FLT PET/CT to X-82 alone (Cycle #1)
  • To determine the change in vascular parameters using FLT PET/CT to X-82 in combination with docetaxel (Cycle #2)
Secondary Objectives
  • To determine the objective response using RECIST 1.1 of intermittent X-82 with docetaxel
  • To measure the change in plasma VEGF levels with changes on FLT PET/CT
  • To measure changes in X-82 pharmacokinetics with changes on FLT PET/CT
NIX-MSN-D1304 Data Set

PET/MRI to Measure Treatment Response in Metastatic Prostate Cancer

Summary

This phase II study assessed the treatment effects on metastatic prostate cancer using FDG and NaF PET/CT and MRI scans and determined the changes in tumor lesion size and bone metastasis.

  • Subjects: 6
  • Layout: mCRPC
  • Data Types: FDG PET/CT, NaF PET/CT/MRI
  • Data Size: 12800

*Disclaimer: Approval Pending

Objectives
Primary Objectives
  • Determine the number of subjects whose tumor lesion size changed after 6 weeks of treatment with ZD4054 using PET and MRI scans.
Secondary Objectives
  • Determine the number of subjects whose tumor lesion size changed using PET imaging alone.
  • Determine the number of subjects whose tumor lesion size changed using diffusion-weighted imaging (DWI)-MRI alone.
  • Determine the number of subjects whose tumor lesion size changed using iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL)-MRI imaging alone.
  • Determine the number of subjects with PSA response.
Learn more

NIX-MSN-D1203 Data Set

FLT-PET/CT Response Assessment in Treated Prostate/Other Solid Malignancy patients

Summary

This phase I study assessed the treatment effects using FLT PET/CT and measured the treatments distribution and effect on various types of cancers in the human body.

  • Subjects: 14
  • Layout: Anti-angiogenic
  • Data Types: FLT PET/CT
  • Data Size: 1760.64

*Disclaimer: Approval Pending

Objective
  • Determine the pharmacodynamic change on FLT-PET/CT [Time Frame: baseline, cycle 1 weeks 2 and 3, pre-cycle 3, cycle 3 weeks 2 and 3]
NIX-MSN-D1111 Data Set

NaF PET/CT in mCRPC Patients Treated with Microtubule Directed Chemo or AR-directed Therapy

Summary

This study evaluated NaF PET/CT imaging to measure changes in bone lesions in CRPC patients when performed in combination with chemotherapy (antimicrotubule directed) and hormone-directed treatment. This study also evaluated the repeatability of the NaF PET/CT scans, compared them to standard CT and bone scans, as well as prostate specific antigen (PSA)

  • Subjects: 56
  • Layout: mCRPC
  • Data Types: NaF PET/ CT
  • Data Size: 31800

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • The repeatability of NaF PET/CT imaging for evaluating bone metastases in patients with metastatic castrate-resistant prostate cancer. [Time Frame: 2 years]
Secondary Objectives
  • Evaluate changes on NaF PET/CT images in response to chemotherapy (antimicrotubule directed chemotherapy) or androgen receptor (AR)-directed therapy. [Time Frame: 2 years]
  • Prostate Specific Antigen (PSA) response [Time Frame: 2 years]
  • Response Evaluation Criteria in Solid Tumors (RECIST) response [Time Frame: 2 years]
  • Radiographic progression free survival [Time Frame: 2 years]
NIX-MSN-D0902 Data Set

FLT PET/CT in Treated Patients with Advanced Solid Malignancies

Summary

This study assessed the pharmacodynamics in patients with advanced solid malignancies using FLT PET/CT scans

  • Subjects: 28
  • Layout: Anti-angiogenic
  • Data Types: FLT PET/CT
  • Data Size: 5784.96

*Disclaimer: Approval Pending

Objectives
Primary Objectives
  • To determine the pharmacodynamic change using FLT-PET/CT scans at baseline, and during Axitinib exposure and washout, in patients with advanced solid malignancies.
  • To evaluate the objective response of Axitinib in patients with advanced solid malignancies.
Secondary Objectives
  • To measure the change in plasma VEGF levels, during Axitinib exposure and withdrawal.
  • To correlate Axitinib pharmacokinetics with response, unexpected toxicity, VEGF levels, and FLT-PET/CT change.

Learn more

NIX-MSN-D1105 Data Set

NaF PET/CT Monitoring in PAP Plus GM-CSF Versus GM-CSF Alone Treatment for Non-Metastatic Prostate Cancer

Summary

This phase II randomized trial of a DNA vaccine encoding Prostatic Acid Phosphatase (pTVG-HP) versus GM-CSF adjuvant in patients with non-metastatic prostate cancer explored new methods to treat prostate cancer and aimed to enhance patient’s immune response against prostate cancer.

  • Subjects: 23 (UW)/11 (JHU)
  • Layout: mCRPC
  • Data Types: NaF PET/CT
  • Data Size: 3300

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • Metastasis-free survival [Time Frame: 2 years]
Secondary Objectives
  • Prostate specific antigen (PSA) doubling time [Time Frame: 2 years]
  • Median time to radiographic disease progression [Time Frame: 2 years]
  • The number and severity of observed toxicities in each arm will be compared [Time Frame: 2 years]
NIX-MSN-D0705 Data Set

Treatment Assessment Using FLT PET/CT in Prostate Cancer

Summary

This phase I trial studied the treatment effects in patients with unresectable or metastatic kidney cancer and other advanced solid tumors using dynamic FLT PET/CT imaging to determine objective response and measured VEGF levels.

  • Subjects: 23
  • Layout: Anti-angiogenic
  • Data Types: FLT PET / CT
  • Data Size: 2500

*Disclaimer: Approval Pending

Objectives
Primary Objectives
  • Determine the pharmacodynamic change using functional imaging (3′-deoxy-3′-[18F] fluorothymidine [FLT]- PET/CT scans) in
    patients with unresectable or metastatic clear cell renal cell carcinoma or other advanced solid malignancies treated with two different
    schedules of sunitinib malate.
  • Evaluate the objective response in patients treated with this drug.
Secondary Objectives
  • Measure the change in plasma vascular endothelial growth factor (VEGF) levels and plasma hypoxia-inducible factor (HIF)1-alpha levels as a potential mechanism for vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) failure and rapid tumor growth following VEGFR TKI withdrawal in these patients.
  • Correlate pharmacokinetics of this drug with response, unexpected toxicity, VEGF levels, HIF1-alpha levels, and FLT-PET/CT scan changes.
Learn more

NIX-MSN-D0611 Data Set

Treatment Effect in Crohn’s Disease Using FLT/FDG PET/CT

Summary

This phase III study measured the corticosteroid-sparing effect of certolizumab pegol in subjects with moderate to severe Crohn’s disease using FDG/FLT PET/CT scans.

  • Subjects: 24
  • Layout: Dogs/RT
  • Data Types: Cu-ATSM PET/FDG PET/FLT PET/CT/DCECT/Dose Plan
  • Data Size: 16977.6

*Disclaimer: Approval Pending

Objectives
Primary Objectives
  • Percentage of Subjects Who Have Been Withdrawn from Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38.
Secondary Objectives
  • Percentage of Subjects with Continuous Remission Off Steroids at Week 38.
  • Cumulative Percentage of Subjects with Relapse/Treatment Failure at Week 38.
  • Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period.
  • Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period.
  • Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period.
  • Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period.
  • Crohn’s Disease Activity Index (CDAI) Score at Week 38.
  • Change from Baseline in CDAI Score at Week 38.
  • Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38.
  • Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38.
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Retrospective Surgery Data Set
Status: Archived, Tracer: FDG, Modality: PET/CT, Primary Cancer: Lung, Treatment: other, Patients: 73, Data Size: 540, Data Types: FDG PET/CT,
NIX ID: MIB009, Layout Standard: Lung Cancer, Study Type: Retrospective
Retrospective Lung (UW15077) Data Set
Status: Archived, Tracer: FDG, Modality: PET/CT, Primary Cancer: Lung, Treatment: Targeted, Patients: 39, Data Size: 1100, Data Types: FDG PET/ CT,
NIX ID: MIB010, Layout Standard: Lung Cancer, Study Type: Retrospective
NIX-MSN-D1512 Data Set

Status: Accrued, Tracer: NaF, Modality: PET/CT, Primary Cancer: Prostate, Treatment: Targeted, Patients: 12, Data Size: 8800, Data Types: NaF PET/CT,
NIX ID: MIB013, Layout Standard: mCRPC, Study Type: Prospective

Retrospective Melanoma (UW14084) Data Set

FDG-PET/CT Retrospective Quantitative Assessment in Advanced Melanoma

Summary

This study will assess the feasibility of longitudinal, real-time monitoring of melanoma progression and response to therapy by conducting research level quantitative analyses of standard-of-care FDG PET/CT imaging.

  • Subjects:20
  • Layout: Immunotherapy Melanoma
  • Data Types: FDG PET/CT
  • Data Size: 53000

*Disclaimer: Approval Pending

Objectives
Primary Objective
  • To retrospectively review patterns of FDG uptake and spatial heterogeneity measures in standard-of-care FDG PET/CT scans in an effort to correlate these quantitative measures with disease progression and response to anti-cancer therapies
Secondary Objectives
  • PET standardized uptake measures (SUV), such as maximum SUV, peak SUV, minimum SUV and total SUV.
  • PET histogram measures, such as Activity Volume Histogram (AVH), and Response Difference Histograms (RDH).
  • PET spatial heterogeneity measures, such as Moran I and Getis G spatial statistics measures.