Malignant MelanomaNCT04253574
Comparison of PET/CT and Ultrasound in Staging of Malignant Melanoma
An observational study of Malignant Melanoma, run by University of Basel.
Trial summary
This is the first study which evaluates the different staging modalities 18F-2-fluoro-2-deoxy-D-glucose PET/CT (PET/CT) and diagnostic ultrasound (US) in a single patient cohort with malignant melanoma (MM). Previous analyses are ambivalent regarding the modality of choice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Imaging with 18F-FDG PET/CT and/or Ultrasound
- How many people
- 258 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 258 patients (112 (43%) women, 146 (57%) men, mean age: 61 ± 16 years) Melanoma subtypes: * nodular subtype (n = 68, 35% of the classified melanomas) * superficial-spreading subtype (n = 61, 32%) * acral lentiginous melanoma (n = 12, 6%) * lentigo maligna (n = 7, 4%) * rare subtypes (n = 44, 23%) * melanoma without characterisation (n = 66) At first diagnosis: * 224 patients (87%) with a primary tumor only * 34 patients (13%) with metastases only Location of the melanoma lesion: * head or neck: 48 patients * trunk: 102 patients * upper limbs: 42 patients * lower limbs: 66 patients
Who may be able to join
- the existence of malignant melanoma (MM) as primary tumour or metastases
Who cannot join
- the non-existence of a malignancy,
- a malignancy other than MM, alone or in combination with an MM
About this study
Official title: Comparison of 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT and Ultrasound in Staging of Patients With Malignant Melanoma: An Analysis in a Single Patient Population
This is the first study which evaluates the different staging modalities 18F-2-fluoro-2-deoxy-D-glucose PET/CT (PET/CT) and diagnostic ultrasound (US) in a single patient cohort with malignant melanoma (MM). Previous analyses are ambivalent regarding the modality of choice. These analyses, however, compared separate patient cohorts for each modality.
Inclusion criteria were a primary staging or re-staging of suspected or confirmed MM with one or more PET/CT and/or one or more US. Exclusion criteria were the non-existence of a malignancy or a malignancy other than MM, alone or in combination with an MM.
Read more
The analysis includes the calculation of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). This was done individually for PET/CT and US, and in PLA also for the combination of these two radiological modalities. Furthermore, US was divided into US as a whole (wUS), peripheral lymph nodes (pUS) and/or abdomen (aUS).
The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in all three analyses. As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.
- Conditions
- Malignant Melanoma
- Being tested
- Imaging with 18F-FDG PET/CT and/or Ultrasound
- Keywords
- Malignant Melanoma, Staging, 18F-FDG PET/CT, Ultrasound
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging with 18F-FDG PET/CT and/or UltrasoundDiagnostic test
All patients were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)) in the search of primary tumors or metastases of their malignant melanomas.
| Study group | Role | What they receive |
|---|---|---|
| Patients with malignant melanoma | 258 patients (w: 112, m: 146 age: 61±16 years) met the primary inclusion criteria. They were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)). Receives: Diagnostic Test: Imaging with 18F-FDG PET/CT and/or Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma
The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.
Measured: September 1998 - August 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Sep 2014
- Primary completion1 Sep 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Principal investigator, Joachim Hohmann, University of Basel
- Investigators
- Joachim Hohmann, MD MSc, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253574
- Sponsor's protocol ID
- UBaselMM
- Status last verified
- Jan 2020
- First submitted
- 26 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xing Y, Bronstein Y, Ross MI, Askew RL, Lee JE, Gershenwald JE, Royal R, Cormier JN. Contemporary diagnostic imaging modalities for the staging and surveillance of melanoma patients: a meta-analysis. J Natl Cancer Inst. 2011 Jan 19;103(2):129-42. doi: 10.1093/jnci/djq455. Epub 2010 Nov 16.
PubMed 21081714
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) PET/CT and Ultrasound in Staging of Patients With Malignant Melanoma: An Analysis in a Single Patient Population
- ClinicalTrials.gov ID
- NCT04253574
- Acronym / sponsor ID
- UBaselMM
- Conditions
- Malignant Melanoma
- Keywords
- Malignant Melanoma, Staging, 18F-FDG PET/CT, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first study which evaluates the different staging modalities 18F-2-fluoro-2-deoxy-D-glucose PET/CT (PET/CT) and diagnostic ultrasound (US) in a single patient cohort with malignant melanoma (MM). Previous analyses are ambivalent regarding the modality of choice. These analyses, however, compared separate patient cohorts for each modality.
Inclusion criteria were a primary staging or re-staging of suspected or confirmed MM with one or more PET/CT and/or one or more US. Exclusion criteria were the non-existence of a malignancy or a malignancy other than MM, alone or in combination with an MM.
The analysis includes the calculation of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). This was done individually for PET/CT and US, and in PLA also for the combination of these two radiological modalities. Furthermore, US was divided into US as a whole (wUS), peripheral lymph nodes (pUS) and/or abdomen (aUS).
The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in all three analyses. As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant melanoma | – | Diagnostic Test: Imaging with 18F-FDG PET/CT and/or Ultrasound258 patients (w: 112, m: 146 age: 61±16 years) met the primary inclusion criteria. They were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 258 patients (112 (43%) women, 146 (57%) men, mean age: 61 ± 16 years) Melanoma subtypes: * nodular subtype (n = 68, 35% of the classified melanomas) * superficial-spreading subtype (n = 61, 32%) * acral lentiginous melanoma (n = 12, 6%) * lentigo maligna (n = 7, 4%) * rare subtypes (n = 44, 23%) * melanoma without characterisation (n = 66) At first diagnosis: * 224 patients (87%) with a primary tumor only * 34 patients (13%) with metastases only Location of the melanoma lesion: * head or neck: 48 patients * trunk: 102 patients * upper limbs: 42 patients * lower limbs: 66 patients
Key inclusion criteria (1 listed)
- the existence of malignant melanoma (MM) as primary tumour or metastases
Key exclusion criteria (2 listed)
- the non-existence of a malignancy,
- a malignancy other than MM, alone or in combination with an MM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging with 18F-FDG PET/CT and/or UltrasoundAll patients were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)) in the search of primary tumors or metastases of their malignant melanomas. | Diagnostic test | Patients with malignant melanoma |
Primary outcome
Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma
Time frame: September 1998 - August 2014
The principle equivalence of the two imaging modalities is set up as a null hypothesis H0 in a per-patient (PPA), per-examination (PEA) and per-lesion analysis (PLA). As a further null hypothesis H0, the equivalence of the combined application compared to the sole applications of the two imaging modalities is asserted. The aim is the refutation of the null hypothesis H0 by significant differences in sensitivity and specificity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 21081714Xing Y, Bronstein Y, Ross MI, Askew RL, Lee JE, Gershenwald JE, Royal R, Cormier JN. Contemporary diagnostic imaging modalities for the staging and surveillance of melanoma patients: a meta-analysis. J Natl Cancer Inst. 2011 Jan 19;103(2):129-42. doi: 10.1093/jnci/djq455. Epub 2010 Nov 16.
- Independent Institute for Quality and Efficiency in Health Care (IQWiG) final report on MM staging \[German\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Hohmann, MD MSc principal investigator
University of Basel
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Melanoma, run by University of Basel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of 18F-FDG PET/CT and ultrasound regarding the detection of primary tumours and metastases of melanoma (time frame: September 1998 - August 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.