Evidence map›Paper›PMID 25945808›Full record

ArticleCancer biotherapy & radiopharmaceuticals2015

First-In-Human Study Demonstrating Tumor-Angiogenesis by PET/CT Imaging with (68)Ga-NODAGA-THERANOST, a High-Affinity Peptidomimetic for αvβ3 Integrin Receptor Targeting.

Richard P Baum, Harshad R Kulkarni, Dirk Müller, Stanley Satz, Narasimhan Danthi, Young-Seung Kim, Martin W Brechbiel

2 registry-linked trialsOpen access · greenAbstract read
In one paragraph

Article in Cancer biotherapy & radiopharmaceuticals, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04469127 phase1 / phase2unknown statusnot on this mapstarted 2024, after this paper: background citation

This Study is a Phase I/II Clinical Evaluation of a New Investigational Agent, Lutetium-177-DOTAGA-IAC (HurlutinTM Lu-177) to Treat Patients With Unresectable Angiogenic Breast Cancer.

TypeinterventionalSponsorAdvanced Imaging Projects, LLCRan2024 to 2025Enrolled100ConditionsBreast Cancer Stage IVArmsLutetium-177-DOTAGA-IAC
NCT04480619 phase1 / phase2not yet recruitingnot on this mapstarted 2025, after this paper: background citation

Safety and Efficacy of Ga-68-IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients.

TypeinterventionalSponsorAdvanced Imaging Projects, LLCRan2025 to 2027Enrolled25ConditionsAngiogenic Breast CancerArmsGa-68-IAC
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. First-in-Human Safety, Imaging, and Dosimetry of a Carbonic Anhydrase IX-Targeting Peptide, [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
    Article
  4. Radionuclide-based theranostics - a promising strategy for lung cancer.European journal of nuclear medicine and molecular imaging · 2023
    Review
  5. Article
  6. Peptidomimetics in cancer targeting.Molecular medicine (Cambridge, Mass.) · 2022
    Review
  7. Review
  8. Review
  9. Radiolabelled Aptamers for Theranostic Treatment of Cancer.Pharmaceuticals (Basel, Switzerland) · 2018
    Review
  10. Prospective ofContrast media & molecular imaging · 2018
    Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Richard P Baum1 THERANOSTICS Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik Bad Berka, ENETS Center of Excellence , Bad Berka, Germany .
Harshad R Kulkarni
Dirk Müller
Stanley Satz
Narasimhan Danthi
Young-Seung Kim
Martin W Brechbiel
European Neuroendocrine Tumor Society · DENational Institutes of Health · USAdvanced Imaging Research (United States) · US

Funding

Metal Chelate Conjugated Monoclonal Antibodies for Tumor Diagnosis and TherapyZIASC006353 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI BRECHBIEL, MARTIN W · 2009 to 2017
$9.4M
Intramural NIH HHS
6 · The paper itself

Abstract

unlabelled(68)Ga-NODAGA-THERANOST™ is an αvβ3 integrin antagonist and the first radiolabeled peptidomimetic to reach clinical development for targeting integrin receptors. In this first-in-human study, the feasibility of integrin receptor peptidomimetic positron emission tomography/computed tomography (PET/CT) imaging was confirmed in patients with non-small-cell lung cancer and breast cancer.

methodsPatients underwent PET/CT imaging with (68)Ga NODAGA-THERANOST. PET images were analyzed qualitatively and quantitatively and compared to 2-deoxy-2-((18)F) fluoro-d-glucose ((18)F-FDG) findings. Images were obtained 60 minutes postinjection of 300-500 MBq of (68)Ga-NODAGA-THERANOST.

results(68)Ga-NODAGA-THERANOST revealed high tumor-to-background ratios (SUVmax=4.8) and uptake at neoangiogenesis sites. Reconstructed fused images distinguished cancers with high malignancy potential and enabled enhanced bone metastasis detection. (18)F-FDG-positive lung and lymph node metastases did not show uptake, indicating the absence of neovascularization.

conclusions(68)Ga-NODAGA-THERANOST was found to be safe and effective, exhibiting in this study rapid blood clearance, stability, rapid renal excretion, favorable biodistribution and PK/PD, low irradiation burden (μSv/MBq/μg), and convenient radiolabeling. This radioligand might enable theranostics, that is, a combination of diagnostics followed by the appropriate therapeutics, namely antiangiogenic therapy, image-guided presurgical assessment, treatment response evaluation, prediction of pathologic response, neoadjuvant-peptidomimetic-radiochemotherapy, and personalized medicine strategies. Further clinical trials evaluating (68)Ga-NODAGA-THERANOST are warranted.

Indexed as

AcetatesAdultBreast NeoplasmsCarcinoma, Non-Small-Cell LungFemaleGallium RadioisotopesHeterocyclic Compounds, 1-RingHumansIntegrin alphaVbeta3MaleMiddle AgedNeovascularization, PathologicPeptidomimeticsPositron-Emission TomographyTissue DistributionTomography, X-Ray Computed1-(1,3-carboxypropyl)-4,7-carboxymethyl-1,4,7-triazacyclononaneAcetatesGallium RadioisotopesHeterocyclic Compounds, 1-RingIntegrin alphaVbeta3Peptidomimetics68Ga-NODAGA-THERANOST™positron emission tomographyαvβ3 receptor targeting

Identifiers

PMID25945808
PMCPMC4426302
OpenAlexW1624224055

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.