Evidence map›Paper›PMID 26983703›Full record

Trial reportMolecular imaging and biology2016

Convenient Preparation of [(68)Ga]DKFZ-PSMA-11 Using a Robust Single-Vial Kit and Demonstration of Its Clinical Efficacy.

Drishty Satpati, Ajit Shinto, K K Kamaleshwaran, Surekha Sane, Sharmila Banerjee

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Molecular imaging and biology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
4.8field-weighted citation impact, top 5% 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

8 citing papers in PubMed, 30 citations in OpenAlex.

  1. Article
  2. Preclinical evaluation and pilot clinical study of [European journal of nuclear medicine and molecular imaging · 2023
    Article
  3. Article
  4. Cold Kit Labeling: The Future ofFrontiers in medicine · 2022
    Review
  5. Article
  6. Review
  7. MedChemComm · 2017
    Article
  8. Quality control and GMP synthesis ofWorld journal of nuclear medicine
    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

5 authors at 2 institutions in 1 country.

Drishty SatpatiRadiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. drishtys77@gmail.com.ORCID 0000-0003-0676-6157
Ajit ShintoNuclear Medicine Department, Kovai Medical Center and Hospital, Coimbatore, India.
K K KamaleshwaranNuclear Medicine Department, Kovai Medical Center and Hospital, Coimbatore, India.
Surekha SaneRadiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India.
Sharmila BanerjeeRadiopharmaceuticals Chemistry Section, Radiochemistry & Isotope Group, Bhabha Atomic Research Centre, Mumbai, India. sharmila@barc.gov.in.
Bhabha Atomic Research Centre · INKovai Medical Center and Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purpose[(68)Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [(68)Ga]DKFZ-PSMA-11 and its clinical use in patients using a "shake-bake-inject" methodology. PROCEDURES: The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using (68)Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer.

results[(68)Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations.

conclusionThe development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.

Indexed as

Reagent Kits, DiagnosticAgedChromatography, High Pressure LiquidGallium RadioisotopesHumansMaleOrganometallic CompoundsPositron Emission Tomography Computed TomographyProstate-Specific AntigenProstatic NeoplasmsRadiopharmaceuticals68Ga-DKFZ-PSMA-11Gallium RadioisotopesOrganometallic CompoundsProstate-Specific AntigenRadiopharmaceuticalsReagent Kits, Diagnostic[68Ga]DKFZ-PSMA-11Freeze-dried kitsPET/CTProstate cancerProstate-specific membrane antigen (PSMA)

Identifiers

PMID26983703
OpenAlexW2330177273

What OpenQuestion holds

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Registered trials

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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.