Evidence map›Paper›PMID 26213947›Full record

ArticlePharmaceuticals (Basel, Switzerland)2015

Toxicological Studies of 212Pb Intravenously or Intraperitoneally Injected into Mice for a Phase 1 Trial.

Diane E Milenic, Alfredo A Molinolo, María S Solivella, Eileen Banaga, Julien Torgue, Sarah Besnainou, Martin W Brechbiel, Kwamena E Baidoo

Open access · goldAbstract read
In one paragraph

Article in Pharmaceuticals (Basel, Switzerland), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.2field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 25 citations in OpenAlex.

  1. Review
  2. Minimising the impact of stableEJNMMI radiopharmacy and chemistry · 2025
    Article
  3. EJNMMI radiopharmacy and chemistry · 2025
    Review
  4. Review
  5. Preclinical Investigation of [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
    Article
  6. Targeted Radium Alpha Therapy in the Era of Nanomedicine: In Vivo Results.International journal of molecular sciences · 2024
    Review
  7. Review
  8. First experience withFrontiers in medicine · 2023
    Article
  9. Article
  10. International journal of radiation biology · 2022
    Article
  11. Development and dosimetry ofEuropean journal of nuclear medicine and molecular imaging · 2019
    Article
  12. Article
  13. Therapeutic Effect of α-EmittingTranslational oncology · 2018
    Article
  14. Nuclear medicine and biology · 2018
    Article
  15. Article
  16. 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

8 authors at 3 institutions in 1 country.

Diane E MilenicRadioimmune & Inorganic Chemistry Section, Radiation Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. milenicd@mail.nih.gov.
Alfredo A MolinoloOral and Pharyngeal Cancer Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, USA. amolinol@mail.nih.gov.
María S SolivellaOral and Pharyngeal Cancer Branch, National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, MD 20892, USA. solivellams@yahoo.com.
Eileen BanagaAreva Med LLC, 4800 Hampden Lane, Suite 200, Bethesda, MD 20817, USA. Eileen.banaga@areva.com.
Julien TorgueAreva Med LLC, 4800 Hampden Lane, Suite 200, Bethesda, MD 20817, USA. Julien.torgue@areva.com.
Sarah BesnainouRadioimmune & Inorganic Chemistry Section, Radiation Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. sarah.besnainou@gmail.com.
Martin W BrechbielRadioimmune & Inorganic Chemistry Section, Radiation Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. martinwb@mail.nih.gov.
Kwamena E BaidooRadioimmune & Inorganic Chemistry Section, Radiation Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA. baidook@mail.nih.gov.
National Cancer Institute · USNational Institutes of Health · USOrano (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
6 · The paper itself

Abstract

Faced with the novelty of a 212Pb-labeled monoclonal antibody (mAb) for clinical translation, concerns were expressed by the Food and Drug Administration (FDA) regarding 212Pb prematurely released from the mAb-chelate conjugate. The objective of this study was to simulate the worst case scenario of such a failure. Groups of Balb/c mice (n = 9-20) were administered 212Pb by intraperitoneal (0.0925-1.85 MBq) or intravenous (0.0925-1.11 MBq) injection and then euthanized at 7 or 90 days to assess acute or chronic effects. Weights were recorded prior to injection of the 212Pb and at the end of the observation periods. Blood samples were collected for clinical chemistry and blood cell analysis. Thirty tissues were harvested and formalin fixed for histopathological examination. Treatment related effects of the 212Pb were observed in the bone marrow, spleen, kidneys and the liver. Histological alterations in these organs were considered mild to moderate, indicating low grade toxicity, and not considered severe enough to affect function. This data was presented to the FDA and determined to be acceptable. The clinical trial with 212Pb-TCMC-trastuzumab was approved in January 2011 and the trial opened at the University of Alabama at Birmingham (UAB) in July.

Indexed as

FDA toxicity studyPb-212radioimmunotherapytargeted alpha-radiation

Identifiers

PMID26213947
PMCPMC4588175
OpenAlexW1790199156

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.