Evidence map›Paper›PMID 32430583›Full record

Trial reportEuropean journal of nuclear medicine and molecular imaging2020

Dosimetry and safety of

Giovanni Paganelli, Anna Sarnelli, Stefano Severi, Maddalena Sansovini, Maria Luisa Belli, Manuela Monti, Flavia Foca, Monica Celli, Silvia Nicolini, Elisa Tardelli and 5 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in European journal of nuclear medicine and molecular imaging, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03454750 (Radiometabolic Therapy), which is not on this map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
4.8field-weighted citation impact, top 4% 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.

NCT03454750 phase2completednot on this mapstarted 2022, after this paper: background citation

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC): Efficacy and Toxicity Evaluation

TypeinterventionalSponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSRan2022 to 2024Enrolled143ConditionsMetastatic Castration Resistant Prostate Cancer, 68Ga-PSMA PET/CT PositiveArms177Lu-PSMA
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Dosimetry of [Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2024
    Pooled it
  2. Joint EANM/SNMMI procedure guideline for the use ofEuropean journal of nuclear medicine and molecular imaging · 2023
    Guideline
  3. The Prostate · 2022
    Pooled it
  4. Pooled it
  5. Trial
  6. The Impact of Monosodium Glutamate onJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021
    Trial
  7. Review
  8. Article
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  10. Review
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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

15 authors at 4 institutions in 1 country.

Giovanni PaganelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Anna SarnelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. anna.sarnelli@irst.emr.it.
Stefano SeveriIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Maddalena SansoviniIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Maria Luisa BelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Manuela MontiIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Flavia FocaIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Monica CelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Silvia NicoliniIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Elisa TardelliIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Irene MariniUnità Operativa Complessa di Medicina Nucleare, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Federica MatteucciIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Melchiore GigantiDipartimento di Morfologia, Chirurgia e Medicina Sperimentale, Università di Ferrara, Ferrara, Italy.
Valentina Di IorioIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Ugo De GiorgiIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
Istituti di Ricovero e Cura a Carattere Scientifico · ITIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Ferrara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeRadioligand therapy (RLT) with PATIENTS AND

methodsA prospective single-arm, open label phase II study on mCRPC was activated at our institute in April 2017. Patients with histologically confirmed advanced mCRPC previously treated with standard life-prolonging agents were enrolled. Folic polyglutamate tablets were orally administered as parotid gland protectors and 500 mL of a 10% mannitol solution was intravenously infused to reduce kidney uptake before the injection of 3.7-5.5 GBq of

resultsForty-three eligible patients were evaluated for toxicity and initial response. Dosimetry was carried out in 13 patients. Two (4.8%) patients had G3 and 8 (19.5%) had G2 hematological toxicity. Only 3 (6.9%) patients had mild G1 salivary gland toxicity and 8 (19.5%) had G1 renal toxicity. A decrease of ≥ 30% in prostate-specific antigen (PSA) was achieved after the first cycle in 17 (40.5%) patients, of whom 13 had a PSA decline of >50% after the second cycle. The median adsorbed doses were 0.65 mGy/MBq (range 0.33-2.63) for parotid glands, 0.42 mGy/MBq (0.14-0.81) for kidneys, 0.036 mGy/MBq (0.023-0.067) for red marrow, and 0.038 mGy/MBq (0.018-0.135) for the whole body.

conclusionIn advanced, heavily pre-treated mCRPC patients, 3.7 GBq/cycle of CLINICAL

trial registrationEU Clinical Trials Register No.: 2016-002732-32; NCT03454750. Collection and assembly of data: April 2017 and February 2019.

Indexed as

Prostatic Neoplasms, Castration-ResistantDipeptidesHeterocyclic Compounds, 1-RingHumansMaleParotid GlandPolyglutamic AcidProspective StudiesProstate-Specific AntigenRadiopharmaceuticalsDipeptidesHeterocyclic Compounds, 1-RingPolyglutamic AcidProstate-Specific AntigenPSMA-617RadiopharmaceuticalsDosimetrymCRPCPolyglutamate tabletsPSMA therapySalivary glands

Identifiers

PMID32430583
OpenAlexW3027729807

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.