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Metastatic Clear Cell Renal Cell CarcinomaEarly Phase 1NCT06428708

[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma

A Early Phase 1 study testing [18F] PSMA-1007 PET/CT in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Western University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
[18F] PSMA-1007 PET/CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteCanada
Study dates
24 Jan 2022to Sep 2025
Phase
Early Phase 1
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

Who may be able to join

  • Men and women with histologically-proven, metastatic renal cell carcinoma (RCC)(TNM stage Tany, Nany, M1)
  • Must have baseline conventional imaging of the chest, abdomen, and pelvis with contrast-enhanced CT or MRI within 5 weeks of enrolment. Contrast is required unless the participant cannot for medical reasons (ie renal failure).
  • Exception: Unenhanced CT of the chest is acceptable Exception: Unenhanced MRI of abdomen and pelvis is acceptable in cases of renal failure

Who cannot join

  • Pregnant or breastfeeding
  • Age less than 18
  • Histology does not have any clear cell component
  • Unable to lie flat for 30 minutes for the scan
  • History of prior malignancy (except non-melanoma skin cancer)
  • Unable to provide informed consent
Show all 9Show fewer
  • Inadequate liver function
  • Systemic or radiation-based cancer treatment is needed urgently and anticipated to begin before PSMA scan can take place
  • Previously exposed to systemic or radiation cancer therapy (except radiation for skin cancer)

Trial locations and contacts

1 site in 1 country.

Kaydee Connors contact

519-685-8500 ext. 56366

kaydee.connors@lhsc.on.ca

Nicole Phillips contact

519-685-8500 ext. 56366

nicole.phillips@lhsc.on.ca

Canada1 site, 1 recruiting

  • London Health Sciences Centre - Victoria Hospital

    London, Ontario, N6A5W9

    Kaydee Connors, 519-685-6366, kaydee.connors@lhsc.on.ca

    Nicole Phillips, 519-685-6366, Nicole.Phillips@lhsc.on.ca

    Recruiting

Other trials in Canada

About this study

Official title: Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

Read the detailed description

This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 26 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.

Being tested
[18F] PSMA-1007 PET/CT
Keywords
PSMA PET, Metastatic clear cell renal cell carcinoma, [18F]PSMA-1007, PSMA
Medical subject headings
Clear-cell metastatic renal cell carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F] PSMA-1007 PET/CTDiagnostic test

    [18F] PSMA-1007 PET/CT scan

Study groups in NCT06428708
Study groupRoleWhat they receive
[18F] PSMA-1007 PET/CTExperimentalAll patients enrolled undergo a [18F] PSMA-1007 PET/CT
Receives: Diagnostic Test: [18F] PSMA-1007 PET/CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of metastatic lesions

    To identify additional metastatic lesions that may not be apparent on conventional cross-sectional imaging during the initial staging process.

    Measured: 5 weeks from initial baseline conventional imaging

  2. Change in management

    To determine the proportion of patients in which results from the PSMA-PET imaging changes management.

    Measured: 1 month

Secondary outcomes (1)

  1. Pathologic correlates

    To determine histopathological correlation in lesions that are biopsied or removed surgically.

    Measured: 1 month or not applicable

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start24 Jan 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428708
Sponsor's protocol ID
ReDA 11465
Status last verified
Jun 2024
First submitted
20 May 2024
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mittlmeier LM, Unterrainer M, Rodler S, Todica A, Albert NL, Burgard C, Cyran CC, Kunz WG, Ricke J, Bartenstein P, Stief CG, Ilhan H, Staehler M. 18F-PSMA-1007 PET/CT for response assessment in patients with metastatic renal cell carcinoma undergoing tyrosine kinase or checkpoint inhibitor therapy: preliminary results. Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):2031-2037. doi: 10.1007/s00259-020-05165-3. Epub 2020 Dec 28.

    PubMed 33369689

  • Giesel FL, Hadaschik B, Cardinale J, Radtke J, Vinsensia M, Lehnert W, Kesch C, Tolstov Y, Singer S, Grabe N, Duensing S, Schafer M, Neels OC, Mier W, Haberkorn U, Kopka K, Kratochwil C. F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Eur J Nucl Med Mol Imaging. 2017 Apr;44(4):678-688. doi: 10.1007/s00259-016-3573-4. Epub 2016 Nov 26.

    PubMed 27889802

  • Rhee H, Blazak J, Tham CM, Ng KL, Shepherd B, Lawson M, Preston J, Vela I, Thomas P, Wood S. Pilot study: use of gallium-68 PSMA PET for detection of metastatic lesions in patients with renal tumour. EJNMMI Res. 2016 Dec;6(1):76. doi: 10.1186/s13550-016-0231-6. Epub 2016 Oct 22.

    PubMed 27771904

  • Yin Y, Campbell SP, Markowski MC, Pierorazio PM, Pomper MG, Allaf ME, Rowe SP, Gorin MA. Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Mol Imaging Biol. 2019 Jun;21(3):567-573. doi: 10.1007/s11307-018-1271-2.

    PubMed 30218388

  • Meyer AR, Carducci MA, Denmeade SR, Markowski MC, Pomper MG, Pierorazio PM, Allaf ME, Rowe SP, Gorin MA. Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted 18F-DCFPyL PET/CT. Ann Nucl Med. 2019 Aug;33(8):617-623. doi: 10.1007/s12149-019-01371-8. Epub 2019 May 30.

    PubMed 31147927

  • Baccala A, Sercia L, Li J, Heston W, Zhou M. Expression of prostate-specific membrane antigen in tumor-associated neovasculature of renal neoplasms. Urology. 2007 Aug;70(2):385-90. doi: 10.1016/j.urology.2007.03.025.

    PubMed 17826525

  • Chang SS, Reuter VE, Heston WD, Gaudin PB. Metastatic renal cell carcinoma neovasculature expresses prostate-specific membrane antigen. Urology. 2001 Apr;57(4):801-5. doi: 10.1016/s0090-4295(00)01094-3.

    PubMed 11306418

  • Kinoshita Y, Kuratsukuri K, Landas S, Imaida K, Rovito PM Jr, Wang CY, Haas GP. Expression of prostate-specific membrane antigen in normal and malignant human tissues. World J Surg. 2006 Apr;30(4):628-36. doi: 10.1007/s00268-005-0544-5.

    PubMed 16555021

  • Prasad V, Steffen IG, Diederichs G, Makowski MR, Wust P, Brenner W. Biodistribution of [(68)Ga]PSMA-HBED-CC in Patients with Prostate Cancer: Characterization of Uptake in Normal Organs and Tumour Lesions. Mol Imaging Biol. 2016 Jun;18(3):428-36. doi: 10.1007/s11307-016-0945-x.

    PubMed 27038316

  • Park JW, Jo MK, Lee HM. Significance of 18F-fluorodeoxyglucose positron-emission tomography/computed tomography for the postoperative surveillance of advanced renal cell carcinoma. BJU Int. 2009 Mar;103(5):615-9. doi: 10.1111/j.1464-410X.2008.08150.x. Epub 2008 Oct 24.

    PubMed 19007371

  • Majhail NS, Urbain JL, Albani JM, Kanvinde MH, Rice TW, Novick AC, Mekhail TM, Olencki TE, Elson P, Bukowski RM. F-18 fluorodeoxyglucose positron emission tomography in the evaluation of distant metastases from renal cell carcinoma. J Clin Oncol. 2003 Nov 1;21(21):3995-4000. doi: 10.1200/JCO.2003.04.073.

    PubMed 14581422

  • Lawrentschuk N, Davis ID, Bolton DM, Scott AM. Functional imaging of renal cell carcinoma. Nat Rev Urol. 2010 May;7(5):258-66. doi: 10.1038/nrurol.2010.40.

    PubMed 20448659

  • Sawicki LM, Buchbender C, Boos J, Giessing M, Ermert J, Antke C, Antoch G, Hautzel H. Diagnostic potential of PET/CT using a 68Ga-labelled prostate-specific membrane antigen ligand in whole-body staging of renal cell carcinoma: initial experience. Eur J Nucl Med Mol Imaging. 2017 Jan;44(1):102-107. doi: 10.1007/s00259-016-3360-2. Epub 2016 Mar 21.

    PubMed 26996777

  • Aide N, Cappele O, Bottet P, Bensadoun H, Regeasse A, Comoz F, Sobrio F, Bouvard G, Agostini D. Efficiency of [(18)F]FDG PET in characterising renal cancer and detecting distant metastases: a comparison with CT. Eur J Nucl Med Mol Imaging. 2003 Sep;30(9):1236-45. doi: 10.1007/s00259-003-1211-4. Epub 2003 Jul 4.

    PubMed 12845486

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F] PSMA-1007 PET/CT in people with Metastatic Clear Cell Renal Cell Carcinoma, run by Western University at 1 site in Canada.

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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kaydee Connors (519-685-8500 ext. 56366, kaydee.connors@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of metastatic lesions (time frame: 5 weeks from initial baseline conventional imaging). The study lists 2 primary outcomes in all. 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 NCT06428708, which also lists 14 linked publications.

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 25 Jun 2024.

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