Table 1.
Human studies for immuno-PET imaging in cancer.
| Clinicaltrials.gov identifier | Tracer | Tracer target | Patient population | Recrutiment site(s)/manufacturer | N | Study details | Estimated completion date |
|---|---|---|---|---|---|---|---|
| NCT03802123 | [89Zr] Df-IAB22M2C | CD8 | Metastatic solid tumors | CARTI Cancer Center, MSKCC/ImaginAb Inc. | 40 | Imaging 1 week prior to and 4–5 weeks after starting cancer therapy. Correlation between [89Zr]-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC on biopsy samples taken around the same timepoints | December 2019 |
| NCT03313323 | [89Zr] ipilimumab | CTLA-4 | Metastatic melanoma planned to get ipilumumab | VU University Medical Center/BMS | 29 | [89Zr] ipilimumab PET imaging 2 h after the first and second dose of ipilumumab | February 2020 |
| NCT03506802 | [18F] FHBG | HSV-1 thymidine kinase gene | Recurrent or refractory multiple myeloma | UCLA Jonsson Comprehensive Cancer Center, National Cancer Institute, California Institute for Regenerative Medicine | 12 | Subjects will be treated with adoptive T-cell transfer with NY-ESO-1 TCR engineered peripheral blood mononuclear cells and peripheral blood stem cells. PET imaging will be performed to determine whether these cells home to the bone marrow, lymph nodes or extramedullary sites | May 2022 |
| NCT03089606 | [11C] AMT | IDO | Metastatic melanoma treated with pembrolizumab | UNC Lineberger Comprehensive Cancer Center/Merck | 25 | [18F] FDG and [11C] AMT PET imaging prior to standard pembrolizumab treatment; pre-treatment biopsies will be performed to correlate to imaging; AMT PET scan SUV levels will be correlated to overall response rate at 12 weeks after initiation of treatment | June 2022 |
| NCT02922283 | [18F] FB-IL-2 | IL2 | Metastatic melanoma | University Medical Center Groningen | 30 | [18F] FB-IL-2 PET at baseline and 6 weeks after therapy with ipilimumab, nivolumab, pembrolizumab or ipilimumab with nivolumab | August 2023 |
| NCT03780725 | [89Zr] BI 754111 | LAG3 | NSCLC and SCCHN | VU Medisch Centrum, Netherlands/Boehringer Ingelheim | 40 | Subjects are treated with the BI 754111 (LAG3 mAb) and BI 754091 (PD-L1 mAb) | July 2020 |
| NCT03065764 | [89Zr] pembrolizumab | PD-1 | NSCLC | VU University/Merck Sharp and Dohme Corp. | 10 | Two [89Zr] pembrolizumab PET scans: one with and one without a preceding ‘cold’ therapeutic dose of pembrolizumab. First three subjects will undergo scans 1, 72, and 120 h after radiotracer injection | December 2019 |
| NCT03520634 | [18F] PD-L1 | PD-L1 | Metastatic melanoma treated with PD-L1 therapy | University Medical Center Groningen | 15 | [18F] PD-L1 scan at baseline and 6 weeks after therapy with paired biopsies if feasible | October 2023 |
| NCT02453984 | [89Zr] atezolizumab | PD-L1 | Locally advanced or metastatic tumors | University Medical Center Groningen | 54 | Fresh pre-treatment and [89Zr] atezolizumab PET scan to be correlated | September 2022 |
| NCT03850028 | [89Zr] atezolizumab | PD-L1 | DLBCL | VU University Medical Center, University Medical Center Groningen, Stichting Hemato-Oncologie voor Volwassenen Nederland/Hoffman-La Roche | 20 | [89Zr] atezolizumab PET at baseline and after induction with R-CHOP; subjects will then get atzolizumab consolidation; re-image at suspected progression | April 2025 |
| NCT03746704 | [89Zr] DFO-REGN3504 | PD-L1 | Advanced thoracic malignancies, gastric cancer and gastroesophageal junction adenocarcinoma | Regeneron | 28 | To establish an adequate mass dose and activity dose of [89Zr] DFO-RGFN3504 and to establish test/re-test reliability on two separate imaging time points | June 2021 |
| NCT03829007 | [89Zr] durvalumab | PD-L1 | SCCHN | Radboud University, University Medical Center Groningen/AstraZeneca | 58 | [89Zr] durvalumab imaging prior to treatment with durvalumab 1500 mg every 4 weeks; correlation with PD-L1 expression performed by Ventana SP263 antibody | March 2021 |
| NCT03853187 | [89Zr] durvalumab | PD-L1 | NSCLC | Radboud University/AstraZeneca | 20 | [89Zr] durvalumab imaging prior to two doses of neoadjuvant durvalumab followed by curative surgery; 48 h prior to surgery injection of ex vivo In-111-oxine labelled autologous CD8+ T cells will be formed and scan on the day of surgery | April 2022 |
| NCT03638804 | [89Zr] KN-035 | PD-L1 | Advanced PD-L1-expressing solid tumors | The First Affiliated Hospital of Soochow University/MITRO Biotech Co., Ltd. | 10 | To evaluate the biodistribution and target lesion uptake of [89Zr] KN035 in patients with PD-L1-positive advanced solid tumors using PET imaging | December 2019 |
| NCT03409419 | [18F] clofarabine | T-cell activation | Metastatic melanoma with progression of disease on PD-1/PD-L1 therapy | UCLA Jonsson Comprehensive Cancer Center, National Cancer Institute/Tesaro Inc | 10 | [18F clofarabine PET before and 2–4 weeks after treatment with TIM3 +/− PD-L1 therapy | August 2021 |
| NCT03007719 | [18F] F-AraG | T-cell activation | Bladder cancer to receive atezolizumab in the neoadjuvant setting as part of a clinical trial or other immunotherapy as standard of care | UCSF/CellSight Technologies | 31 | Cohort 1: [18F] F-AraG PET/MRI prior to neoadjuvant atezolizumab then prior to surgery. Cohort 2: [18F] F-AraG PET/MRI before standard immunotherapy and on cycle 1 day 15 and cycle 2 day 7 of treatment | December 2019 |
| NCT03129061 | [18F] F-AraG | T-cell activation | SCCHN | Stanford University/CellSight Technologies | 24 | Cohort 1: unresectable SCCHN treated with pembrolizumab imaged at baseline then 6–12 weeks after dose. Cohort 2: neoadjuvant pembrolizumab with imaging at baseline and 2–3 weeks after dose | June 2019 |
| NCT03142204 | [18F] F-AraG | T-cell activation | Patients getting radiation therapy or immunotherapy | UCSF/CellSight Technologies | 30 | [18F]F-AraG PET at baseline and after start of treatment | May 2021 |
| NCT03311672 | [18F] F-AraG | T-cell activation | NSCLC | UCSF/CellSight Technologies | 20 | [18F]F-AraG PET in patients receiving immunotherapy alone or with radiation. The correlation between number of infiltrating CD3+ T cells/μm2 in the NSCLC thoracotomy specimen as quantified by IHC and the activated T-cell concentration as determined by [18F]F-AraG PET (SUVmax) | December 2020 |
A search performed on Clinicaltrials.gov using search terms ‘cancer’ and ‘PET’ that were not yet recruiting, recruiting, and active not recruiting yielded 1300 studies. Trials targeting immune mechanisms in cancer were selected from this larger list.
18F-AraG, 2'-deoxy-2'-18F fluoro-9β-D-arabinofuranosyl-guanine; AMT, alpha-methyltryptophan; BMS, Bristol-Myers Squibb; CTLA-4, cytotoxic T-lymphocyte-associated antigen-4; DLBCL, diffuse large B-cell lymphoma; FDG, fluorodeoxyglucose; [18F]FHBG, 9-(4-(18)F-Fluoro-3-[hydroxymethyl]butyl)guanine; HSV-1, herpes simplex virus type 1; IDO, indoleamine 2,3-dioxygenase; IHC, immunohistochemistry; IL-2, interleukin-2; MRI, magnetic resonance imaging; MSKCC, Memorial Sloan Kettering Cancer Center; NSCLC, non-small-cell lung cancer; PD-1, programmed cell death protein-1; PD-L1, programmed cell death ligand-1; PET, positron emission tomography; R-CHOP, rituxumab, cyclophosphamide, doxorubicin, vincristine, prednisone; SCCHN, squamous cell cancer of the head and neck; SUV, standard uptake value; TCR, T-cell receptor; UCLA, University of California, Los Angeles; UCSF, University of California, San Francisco; VU, Vrije Universiteit.