Proceedings: Pathways for Successful Translation of New Imaging Agents and Modalities—Phase III Studies

Gambhir, Sanjiv S.; Shankar, Lalitha; Rosenthal, Eben L.; Warram, Jason M.; Ghesani, Munir; Hope, Thomas A.; Jacobs, Paula; Jacobson, Gunilla B.; Wilson, T. G.; Siegel, Barry A.

doi:10.2967/jnumed.118.219824

Cited by 6 publications

(7 citation statements)

References 45 publications

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“…The translation of radiotracers such as 99m Tc-PSMA I&S was supported by the ability to apply these tracers in a microdosing regime, a concept that limits toxicity and eases the clinical translation of radiotracers . Despite clinical data indicating that fluorescence-guided surgery might also be feasible adhering to the microdosing principle, ,, as has also been suggested for PSMA using a porcine model (Figure D), the application of microdosing remains controversial in the field of fluorescence-guided surgery . It is certain, however, that intraoperative identification of (fluorescent) lesions is less efficient when they contain low tracer concentrations .…”

Section: Discussionmentioning

confidence: 99%

“…119 Despite clinical data indicating that fluorescence-guided surgery might also be feasible adhering to the microdosing principle, 73,120,121 as has also been suggested for PSMA using a porcine model (Figure 4D), the application of microdosing remains controversial in the field of fluorescenceguided surgery. 122 It is certain, however, that intraoperative identification of (fluorescent) lesions is less efficient when they contain low tracer concentrations. 73 Other than PSMA−PET studies reporting on a >2 mm size limit for lesion identification, 55 little is known about the PSMA concentration on cancer cells in primary or metastatic lesions.…”

Section: ■ Discussionmentioning

confidence: 99%

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Image-Guided Surgery: Are We Getting the Most Out of Small-Molecule Prostate-Specific-Membrane-Antigen-Targeted Tracers?

et al. 2019

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Expressed on virtually all prostate cancers and their metastases, the transmembrane protein prostate-specific membrane antigen (PSMA) provides a valuable target for the imaging of prostate cancer. Not only does PSMA provide a target for noninvasive diagnostic imaging, e.g., PSMA-positron emission tomography (PSMA–PET), it can also be used to guide surgical resections of PSMA-positive lesions. The latter characteristic has led to the development of a plethora of PSMA-targeted tracers, i.e., radiolabeled, fluorescent, or hybrid. With image-guided surgery applications in mind, this review discusses these compounds based on clinical need. Here, the focus is on the chemical aspects (e.g., imaging label, spacer moiety, and targeting vector) and their impact on in vitro and in vivo tracer characteristics (e.g., affinity, tumor uptake, and clearance pattern).

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Section: Discussionmentioning

confidence: 99%

Section: ■ Discussionmentioning

confidence: 99%

Image-Guided Surgery: Are We Getting the Most Out of Small-Molecule Prostate-Specific-Membrane-Antigen-Targeted Tracers?

et al. 2019

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“…There are two pathways for CMS coverage, local coverage determination (LCD) and national coverage determination (NCD) [ 48 •]. Claims for medical products and services under Medicare Parts A and B are processed by twelve Medicare Administrative Contractors (MACs) in their geographic regions in the USA.…”

Section: Cms Coverage Of Petmentioning

confidence: 99%

“…Medicare has used NCDs and CED extensively for PET [ 48 •], and its focus on health outcomes is particularly relevant. In 2000, CMS clarified that the primary factors to determine if a new technology is “reasonable and necessary” included not only whether it is safe, effective, and appropriate, but also whether it leads to improved health outcomes [ 46 ].…”

Section: Cms Coverage Of Petmentioning

confidence: 99%

Regulatory Agencies and PET/CT Imaging in the Clinic

Herscovitch

2022

Curr Cardiol Rep

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Purpose of Review The regulatory steps necessary to bring new PET radiopharmaceuticals to the clinic will be reviewed. The US Food and Drug Administration (FDA) provides approval to manufacture and use diagnostic radiopharmaceuticals, including those for cardiovascular PET/CT. Medicare not only provides insurance reimbursement for imaging procedures for its beneficiaries but also sets an example for third-party insurers to cover these procedures. Recent Findings FDA provides extensive guidance for performing studies to obtain the safety and efficacy data needed to approve PET radiopharmaceuticals, and the pace of approval has recently increased. There also has been considerable progress in insurance coverage for PET by Medicare. Several promising agents for cardiovascular PET imaging are in the development pipeline. Challenges remain, however, including low levels of reimbursement and the application of appropriate use criteria for imaging procedures. Summary It is important for cardiologists to understand the regulatory steps involved in translating PET radiopharmaceuticals to the clinic. Recent progress in both FDA approvals and Medicare coverage should facilitate the clinical use of new PET agents for molecular imaging of the heart.

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“…[115][116][117][118][119][120] Moreover, OTL38, an NIRF agent binding with folate receptor-α has entered Phase III clinical trial stage for patients with ovarian cancer [121] and Phase II clinical trial stage for patients with pulmonary adenocarcinomas. Rosenthal and co-workers devoted a considerable amount of efforts in researching tumor-specific fluorescent probes by conjugating antibodies (e.g., panitumumab, cetuximab, etc.)…”

Section: Fluorescence Imagingmentioning

confidence: 99%

Advanced Nanotechnology Leading the Way to Multimodal Imaging‐Guided Precision Surgical Therapy

et al. 2019

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Surgical resection is the primary and most effective treatment for most patients with solid tumors. However, patients suffer from postoperative recurrence and metastasis. In the past years, emerging nanotechnology has led the way to minimally invasive, precision and intelligent oncological surgery after the rapid development of minimally invasive surgical technology. Advanced nanotechnology in the construction of nanomaterials (NMs) for precision imaging-guided surgery (IGS) as well as surgery-assisted synergistic therapy is summarized, thereby unlocking the advantages of nanotechnology in multimodal IGS-assisted precision synergistic cancer therapy. First, mechanisms and principles of NMs to surgical targets are briefly introduced. Multimodal imaging based on molecular imaging technologies provides a practical method to achieve intraoperative visualization with high resolution and deep tissue penetration. Moreover, multifunctional NMs synergize surgery with adjuvant therapy (e.g., chemotherapy, immunotherapy, phototherapy) to eliminate residual lesions. Finally, key issues in the development of ideal theranostic NMs associated with surgical applications and challenges of clinical transformation are discussed to push forward further development of NMs for multimodal IGS-assisted precision synergistic cancer therapy.

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Proceedings: Pathways for Successful Translation of New Imaging Agents and Modalities—Phase III Studies

Cited by 6 publications

References 45 publications

Image-Guided Surgery: Are We Getting the Most Out of Small-Molecule Prostate-Specific-Membrane-Antigen-Targeted Tracers?

Image-Guided Surgery: Are We Getting the Most Out of Small-Molecule Prostate-Specific-Membrane-Antigen-Targeted Tracers?

Regulatory Agencies and PET/CT Imaging in the Clinic

Advanced Nanotechnology Leading the Way to Multimodal Imaging‐Guided Precision Surgical Therapy

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